Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01977573
Registration number
NCT01977573
Ethics application status
Date submitted
24/10/2013
Date registered
6/11/2013
Date last updated
12/10/2018
Titles & IDs
Public title
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
Query!
Scientific title
A 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.
Query!
Secondary ID [1]
0
0
113747
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Anaemia
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Blood
0
0
0
0
Query!
Anaemia
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - GSK1278863
Treatment: Drugs - rhEPO
Experimental: GSK1278863 - Subjects will be administered GSK1278863 QD. Starting dose will be based on data from previous studies with GSK1278863 and dose-response modelling, as well as Baseline Hgb concentration. After 4 Week of fixed dose period, dose may be adjusted to achieve Hgb 9.0 to 10.5 g/dL
Other: Control - All subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, to maintain Hgb levels within the target range. The decision around whether a subject requires rhEPO, selection of the type of rhEPO and rhEPO dose should be based on Investigator clinical judgment, with the historical rhEPO dose (where applicable) and the current Hgb value being considered.
Treatment: Drugs: GSK1278863
Film-coated tablets containing 0.5 mg, 1 mg, 2 mg, 5mg or matching placebo
Treatment: Drugs: rhEPO
Locally sourced rhEPO. All subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, to maintain Hgb levels within the target range. The decision around whether a subject requires rhEPO, selection of the type of rhEPO and rhEPO dose should be based on Investigator clinical judgment, with the historical rhEPO dose (where applicable) and the current Hgb value being considered..
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Summary of Hemoglobin (Hgb) Concentration at Week 24
Query!
Assessment method [1]
0
0
The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original criteria ("Original") and those following the amended ("Amended") criteria. The primary objective was to characterize the ability of GSK1278863 to achieve mean Hgb response within the target range.
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24
Query!
Assessment method [1]
0
0
Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [2]
0
0
Number of Participants Reaching Pre-defined Hgb Stopping Criteria
Query!
Assessment method [2]
0
0
The Hgb stopping criteria was a value of <7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure.
Query!
Timepoint [2]
0
0
Over a period of 24 Weeks
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline in Hepcidin Concentration at Week 24
Query!
Assessment method [3]
0
0
Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value.
Query!
Timepoint [3]
0
0
Baseline and Week 24
Query!
Secondary outcome [4]
0
0
Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)
Query!
Assessment method [4]
0
0
Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baseline values minus the Baseline value.
Query!
Timepoint [4]
0
0
Baseline to Week 24
Query!
Secondary outcome [5]
0
0
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)
Query!
Assessment method [5]
0
0
Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-baseline values minus the Baseline value.
Query!
Timepoint [5]
0
0
Baseline and up to Week 24
Query!
Secondary outcome [6]
0
0
Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24
Query!
Assessment method [6]
0
0
The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.
Query!
Timepoint [6]
0
0
Weeks 12 to 24
Query!
Secondary outcome [7]
0
0
Change From Baseline in Ferritin Concentration at Week 24
Query!
Assessment method [7]
0
0
Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value.
Query!
Timepoint [7]
0
0
Baseline and Week 24
Query!
Secondary outcome [8]
0
0
Change From Baseline in Transferrin Concentration at Week 24
Query!
Assessment method [8]
0
0
Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value.
Query!
Timepoint [8]
0
0
Baseline and Week 24
Query!
Secondary outcome [9]
0
0
Percent Change From Baseline in Transferrin Saturation at Week 24
Query!
Assessment method [9]
0
0
Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value.
Query!
Timepoint [9]
0
0
Baseline and Week 24
Query!
Secondary outcome [10]
0
0
Change From Baseline in Total Iron at Week 24
Query!
Assessment method [10]
0
0
Baseline is the last pre-dose total iron value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.
Query!
Timepoint [10]
0
0
Baseline and Week 24
Query!
Secondary outcome [11]
0
0
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24
Query!
Assessment method [11]
0
0
TIBC measures the blood's capacity to bind iron with transferrin. Baseline is the last pre-dose TIBC value. Change from Baseline in TIBC was calculated by subtracting the Baseline value from the Week 24 value.
Query!
Timepoint [11]
0
0
Baseline and Week 24
Query!
Secondary outcome [12]
0
0
Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24
Query!
Assessment method [12]
0
0
Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value.
Query!
Timepoint [12]
0
0
Baseline and Week 24
Query!
Secondary outcome [13]
0
0
Change From Baseline in Hematocrit at Week 24
Query!
Assessment method [13]
0
0
Baseline is the last pre-dose hematocrit value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.
Query!
Timepoint [13]
0
0
Baseline and Week 24
Query!
Secondary outcome [14]
0
0
Change From Baseline in Red Blood Cell Count at Week 24
Query!
Assessment method [14]
0
0
Baseline is the last pre-dose red blood cell count. Change from Baseline in red blood cell count was calculated by subtracting the Baseline count from the post-dose count.
Query!
Timepoint [14]
0
0
Baseline and Week 24
Query!
Secondary outcome [15]
0
0
Change From Baseline in Reticulocyte Cell Count at Week 24
Query!
Assessment method [15]
0
0
Reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline is the last pre-dose red reticulocyte count. Change from Baseline in reticulocyte cell count was calculated by subtracting the Baseline count from the Week 24 count.
Query!
Timepoint [15]
0
0
Baseline and Week 24
Query!
Secondary outcome [16]
0
0
Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint
Query!
Assessment method [16]
0
0
Blood samples were collected for individual plasma GSK1278863 and metabolite (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, and GSK2531403) concentration measurement on Day 1 (pre-dose), Wk 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose). Participants available in each arm at the specified time points have been presented.
Query!
Timepoint [16]
0
0
Day 1 (pre-dose), Week (Wk) 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose)
Query!
Secondary outcome [17]
0
0
Mean Number of Dose Adjustments up to 24 Weeks
Query!
Assessment method [17]
0
0
After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system.
Query!
Timepoint [17]
0
0
From Week 4 up to 24 Weeks
Query!
Secondary outcome [18]
0
0
Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency
Query!
Assessment method [18]
0
0
After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. Frequency is presented as the number of participants with dose adjustment(s) once, twice, thrice, four times, or five times.
Query!
Timepoint [18]
0
0
From week 4 up to 24 weeks
Query!
Secondary outcome [19]
0
0
Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20
Query!
Assessment method [19]
0
0
After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. The number of participants with an adjustment are presented at the timings at which adjustments were done.
Query!
Timepoint [19]
0
0
From Week 4 up to Week 20
Query!
Secondary outcome [20]
0
0
Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks
Query!
Assessment method [20]
0
0
The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.
Query!
Timepoint [20]
0
0
Up to 24 Weeks
Query!
Secondary outcome [21]
0
0
Mean Final Dose of GSK1278863 up to 24 Weeks
Query!
Assessment method [21]
0
0
The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.
Query!
Timepoint [21]
0
0
Up to 24 Weeks
Query!
Secondary outcome [22]
0
0
Number of Hemoglobin (Hgb) Excursions
Query!
Assessment method [22]
0
0
A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. Hgb cycle is calculated as two consecutive Hgb excursions in different directions.
Query!
Timepoint [22]
0
0
Up to 24 Weeks.
Query!
Secondary outcome [23]
0
0
Number of Hemoglobin (Hgb) Cycles up to 24 Weeks
Query!
Assessment method [23]
0
0
A Hgb cycle is calculated as two consecutive Hgb excursions in different directions. A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.
Query!
Timepoint [23]
0
0
Up to 24 Weeks
Query!
Secondary outcome [24]
0
0
Number of Dose Cycles up to 24 Weeks
Query!
Assessment method [24]
0
0
A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease).
Query!
Timepoint [24]
0
0
Up to 24 weeks
Query!
Secondary outcome [25]
0
0
Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks.
Query!
Assessment method [25]
0
0
A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.
Query!
Timepoint [25]
0
0
Up to 24 weeks
Query!
Secondary outcome [26]
0
0
Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks
Query!
Assessment method [26]
0
0
A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. A Hgb cycle is two consecutive Hgb excursions in different directions.
Query!
Timepoint [26]
0
0
Up to 24 weeks
Query!
Secondary outcome [27]
0
0
Number of Participants With at Least One Dose Cycle up to 24 Weeks
Query!
Assessment method [27]
0
0
A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants
Query!
Timepoint [27]
0
0
Up to 24 weeks
Query!
Secondary outcome [28]
0
0
Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline
Query!
Assessment method [28]
0
0
Participants receiving additional therapies of blood transfusions, intravenous (IV) iron or rhEPO any time Post Baseline were analyzed. RhEPO was not applicable for the control arms since it was a planned therapy in those arms, hence presented as NA. (EudraCT only: A value of 99999 is used where no data is available or NA.)
Query!
Timepoint [28]
0
0
From Day 1 up to Week 28
Query!
Secondary outcome [29]
0
0
Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit
Query!
Assessment method [29]
0
0
Number of Weeks dose was withheld because hemoglobin exceed the upper limit is presented as the number of participants with withheld dose during the time periods categorized by Weeks.
Query!
Timepoint [29]
0
0
From Week 4 up to Week 24
Query!
Eligibility
Key inclusion criteria
- Age: >=18 years of age. (Week -4 verification only)
- Gender: Female and male subjects. (Week -4 verification only) Females: If of
childbearing potential, must agree to use one of the approved contraception methods,
from Screening until completion of the Follow-up Visit OR Of non-childbearing
potential defined as pre-menopausal females with a documented tubal ligation,
hysterectomy, or oophorectomy; or postmenopausal defined as 12 months of spontaneous
amenorrhea. Females on hormone replacement therapy (HRT) whose menopausal status is in
doubt will be required to use one of the approved contraception methods if they wish
to continue their HRT during the study. Otherwise they must discontinue HRT to allow
confirmation of post-menopausal status prior to study enrolment.
- Corrected QT interval (QTc): Bazett's Correction of QT Interval (QTcB) <470
milliseconds (msec) or QTcB <480 msec in subjects with bundle branch block. There is
no QTc criterion for subjects with a predominantly paced rhythm.
- CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3/4/5 defined
by electronic estimated glomerular filtration rate (eGFR) using the CKD Epidemiology
Collaboration (CKD-EPI) formula.
- Hgb: Group 1 (rhEPO naïve): Baseline Hgb of 8.0-11.0 g/dL (inclusive) (USA sites only:
8.0-10.0 g/dL, inclusive); Group 2 (rhEPO users): Baseline Hgb of 9.0-11.5 g/dL
(inclusive) (USA sites only: 9.0-10.5, inclusive).
- Stable rhEPO dose for rhEPO users: Group 2 subjects must be using the same rhEPO
(epoetins or their biosimilars, or darbepoetin) with total weekly doses that varied by
no more than 50% during the 4 weeks prior to Week -4. At Day 1 (randomization),
confirm that total weekly doses varied by no more than 50% during the screening
period.
- Oral iron therapy: If on oral iron, then doses must not be changed for the 4 weeks
prior to Week -4, during the screening phase, and through the first 4 weeks after
Randomization.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Dialysis: On dialysis or planning to initiate dialysis during the study.
- Renal transplant: Pre-emptive or scheduled renal transplant.
- High rhEPO dose: An epoetin dose of >=360 IU/kg/week intravenous (IV) or >=250
IU/kg/week subcutaneous (SC) or darbepoetin dose of >=1.8 microgram per kilogram per
week (mcg/kg/week) IV or SC within the prior 8 weeks through Day 1 (randomization).
- Use of methoxy polyethylene glycol epoetin beta within the prior 8 weeks through Day 1
(randomization).
- IV iron therapy: Use of IV iron for 4 weeks prior to Screening Week -4, during the
screening phase, and through the first 4 weeks after Randomization
- Vitamin B12: Below the lower limit of the reference range (may rescreen in a minimum
of 8 weeks).
- Folate: <2.0 nanogram per millilitre (ng/mL) (<4.5 nanomoles per liter [nmol/L]) (may
rescreen in a minimum of 4 weeks).
- Ferritin: <40 ng/mL (<40 mcg/L).
- Transferrin saturation (TSAT): Below the lower limit of the reference range
- Myocardial infarction or acute coronary syndrome: Within the 8 weeks prior to
Screening through Day 1 (randomization).
- Stroke or transient ischemic attack: Within the 8 weeks prior to Week -4 Screening
through Day 1 (randomization).
- Heart failure: Class III/IV heart failure as defined by the New York Heart Association
(NYHA) functional classification system diagnosed prior to Week -4 Screening through
Day 1 (randomization), symptomatic right heart failure diagnosed prior to Week -4
Screening through Day 1 (randomization).
- Uncontrolled hypertension: Defined as diastolic blood pressure (DBP) >100 mmHg or
systolic blood pressure (SBP) >170 mmHg at Week -4 and reconfirmed at Day 1.
- Thrombotic Disease: History of thrombotic disease (e.g., venous thrombosis such as
deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset
or worsening limb ischemia requiring intervention), except vascular access thrombosis
within the 8 weeks prior to Week -4 Screening through Day 1 (randomization).
- Ophthalmology disease: Meeting any ophthalmologic-related exclusion criteria
determined at the Screening ophthalmology exam.
- Inflammatory disease: Active chronic inflammatory disease that could impact
erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis,
celiac disease) diagnosed prior to Week -4 Screening through Day 1 (randomization).
- Hematological disease: Any hematological disease including those affecting platelets,
white or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes,
hematological malignancy, myeloma, hemolytic anemia and thalassemia), coagulation
disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other
cause of anemia other than renal disease diagnosed prior to Week -4 Screening through
Day 1 (randomization).
- Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the
exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening
of abnormal liver function tests [alanine transaminase (ALT) or aspartate transaminase
(AST) >2.0 x upper limit of normal (ULN) or total bilirubin >1.5 x ULN]; or other
hepatic abnormalities that in the opinion of the investigator would preclude the
subject from participation in the study.
- Major surgery: Major surgery (excluding vascular access surgery) within the prior 8
weeks, during the Week -4 Screening phase or planned during the study.
- Transfusion: Blood transfusion within the prior 8 weeks, during the Week -4 Screening
phase or an anticipated need for blood transfusion during the study.
- Gastrointestinal (GI) Bleeding: Evidence of actively bleeding peptic, duodenal, or
esophageal ulcer disease OR clinically significant GI bleeding within the 8 weeks
prior to Week -4 Screening through Day 1 (randomization).
- Acute infection: Clinical evidence of acute infection or history of infection
requiring IV antibiotic therapy within the 8 weeks prior to Week -4 Screening through
Day 1 (randomization).
- Malignancy: Subjects with a history of malignancy within the prior 5 years, who
receiving treatment for cancer, or who have a strong family history of cancer (e.g.,
familial cancer disorders); with the exception of squamous cell or basal cell
carcinoma of the skin that has been definitively treated prior to Week -4 Screening
through Day 1 (randomization).
- Severe allergic reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product (see GSK1278863 IB for
list of excipients and rhEPO (refer to local product labelling for details).
- Drugs and supplements: Use of any prescription or non-prescription drugs or dietary
supplements that are prohibited from Week -4 Screening until the Follow-up Visit.
- Prior investigational product exposure: The Subject has participated in a clinical
trial and has received an experimental investigational product within the prior 30
days from Week -4 Screening through Day 1 (randomization).
- Other Conditions: Any other condition, clinical or laboratory abnormality, or
examination finding that the Investigator considers would put the subject at
unacceptable risk.
- Patient participation: Unwillingness or inability of the subject to follow the
procedures or lifestyle or dietary restrictions outlined in the protocol.
- Pregnancy or Lactation: Pregnant females as determined by positive urine human
chorionic gonadotropin (hCG) test OR women who are lactating at Week -4 Screening or
during the trial.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/10/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/06/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
252
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Liverpool
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Westmead
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Adelaide
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Tennessee
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Utah
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Alberta
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Ontario
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Quebec
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Cheb
Query!
Country [17]
0
0
Czechia
Query!
State/province [17]
0
0
Liberec
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Louny
Query!
Country [19]
0
0
Czechia
Query!
State/province [19]
0
0
Marianske Lazne
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Most
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Praha 10
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Praha 2
Query!
Country [23]
0
0
Czechia
Query!
State/province [23]
0
0
Praha 4
Query!
Country [24]
0
0
Czechia
Query!
State/province [24]
0
0
Sokolov
Query!
Country [25]
0
0
Denmark
Query!
State/province [25]
0
0
Odense C
Query!
Country [26]
0
0
Denmark
Query!
State/province [26]
0
0
Roskilde
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Amiens cedex 1
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Bordeaux
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Caen Cedex 9
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Créteil Cedex
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Lyon Cedex 03
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Paris Cedex 15
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Sainte Foy-Lès-Lyon
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Baden-Wuerttemberg
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Bayern
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Mecklenburg-Vorpommern
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Nordrhein-Westfalen
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Sachsen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Berlin
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Hamburg
Query!
Country [41]
0
0
Hungary
Query!
State/province [41]
0
0
Budapest
Query!
Country [42]
0
0
Hungary
Query!
State/province [42]
0
0
Székesfehérvár
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Aichi
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Gifu
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Gunma
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Ibaraki
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Kanagawa
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Kyoto
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Nagano
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Osaka
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Shiga
Query!
Country [52]
0
0
Korea, Republic of
Query!
State/province [52]
0
0
Anyang-Si Gyeonggi-do
Query!
Country [53]
0
0
Korea, Republic of
Query!
State/province [53]
0
0
Daegu
Query!
Country [54]
0
0
Korea, Republic of
Query!
State/province [54]
0
0
Daejeon
Query!
Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Gwangju
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Krakow
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Lublin
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Tarnow
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Warszawa
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Zabrze
Query!
Country [61]
0
0
Russian Federation
Query!
State/province [61]
0
0
Izhevsk
Query!
Country [62]
0
0
Russian Federation
Query!
State/province [62]
0
0
Kaluga
Query!
Country [63]
0
0
Russian Federation
Query!
State/province [63]
0
0
Khantymansiysk
Query!
Country [64]
0
0
Russian Federation
Query!
State/province [64]
0
0
Krasnodar
Query!
Country [65]
0
0
Russian Federation
Query!
State/province [65]
0
0
Krasnoyarsk
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Moscow
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
St-Petersburg
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Ulyanovsk
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Yaroslavl
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Alcala de Henares
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Badalona
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Barcelona
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Cordoba
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Granada
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Madrid
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
San Sebastian de los Reyes
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Santander
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Santiago de Compostela
Query!
Country [79]
0
0
Sweden
Query!
State/province [79]
0
0
Göteborg
Query!
Country [80]
0
0
Sweden
Query!
State/province [80]
0
0
Karlstad
Query!
Country [81]
0
0
Sweden
Query!
State/province [81]
0
0
Stockholm
Query!
Country [82]
0
0
Sweden
Query!
State/province [82]
0
0
Uppsala
Query!
Country [83]
0
0
Sweden
Query!
State/province [83]
0
0
Örebro
Query!
Country [84]
0
0
United Kingdom
Query!
State/province [84]
0
0
Chelmsford
Query!
Country [85]
0
0
United Kingdom
Query!
State/province [85]
0
0
Dorchester
Query!
Country [86]
0
0
United Kingdom
Query!
State/province [86]
0
0
Dundee
Query!
Country [87]
0
0
United Kingdom
Query!
State/province [87]
0
0
Hull
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
Leeds
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
London
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Manchester
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will be conducted in approximately 228 subjects with anemia associated with CKD
who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1:
recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are
currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either
GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO
before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the
control arm. For those randomized to the control arm, the decision around whether the subject
requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose
to achieve and maintain Hgb concentrations within the target range should be based on
Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value
being considered. The study consists of a screening phase of at least 4 weeks, a 24-week
treatment phase and a follow-up visit that will occur approximately 4 weeks after completing
treatment. It is anticipated that the data generated will enable selection of the starting
dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01977573
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01977573
Download to PDF