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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01977482




Registration number
NCT01977482
Ethics application status
Date submitted
24/10/2013
Date registered
6/11/2013
Date last updated
8/06/2018

Titles & IDs
Public title
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
Scientific title
A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin
Secondary ID [1] 0 0
113633
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1278863
Treatment: Drugs - Placebo
Treatment: Drugs - rhEPO

Experimental: GSK1278863 4 mg - Subjects will take GSK1278863 4 mg blinded once daily (OD) orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24.

Experimental: GSK1278863 6 mg - Subjects will take GSK1278863 6 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24.

Experimental: GSK1278863 8 mg - Subjects will take GSK1278863 8 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24.

Experimental: GSK1278863 10 mg - Subjects will take GSK1278863 10 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24.

Experimental: GSK1278863 12 mg - Subjects will take GSK1278863 12 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24.

Active Comparator: Control - Subjects will take GSK1278863 matching placebo blinded OD orally for 4 weeks with a glass of water. From Week 4, rhEPO will be administered and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24.


Treatment: Drugs: GSK1278863
Film coated tablets containing 1 mg, 2 mg, 5 mg, or 25 mg of GSK1278863

Treatment: Drugs: Placebo
Matching placebo tablet for GSK1278863

Treatment: Drugs: rhEPO
rhEPO will be procured from local market
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Hemoglobin (Hgb) at Week 4
Timepoint [1] 0 0
Baseline (Week -4, Week-2 and Day 1) and Week 4
Secondary outcome [1] 0 0
Hgb Concentration at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24
Timepoint [2] 0 0
Week 20 to Week 24
Secondary outcome [3] 0 0
Number of Participants With Hgb in the Target Range at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Number of Participants Reaching Pre-defined Hgb Stopping Criteria
Timepoint [4] 0 0
Up to 24 weeks
Secondary outcome [5] 0 0
Maximum Observed Change From Baseline in Erythropoietin (EPO)
Timepoint [5] 0 0
Baseline (Day 1) to Week 28
Secondary outcome [6] 0 0
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)
Timepoint [6] 0 0
Baseline (Day 1) to Week 28
Secondary outcome [7] 0 0
Population Plasma PK Parameters of GSK1278863 and Metabolites
Timepoint [7] 0 0
Day 1, Week 4, and Week 20
Secondary outcome [8] 0 0
Percent Change From Baseline in Hepcidin at Week 24
Timepoint [8] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [9] 0 0
Change From Baseline in Ferritin at Week 24
Timepoint [9] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [10] 0 0
Change From Baseline in Transferrin at Week 24
Timepoint [10] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [11] 0 0
Percent Change From Baseline in Transferrin Saturation at Week 24
Timepoint [11] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [12] 0 0
Change From Baseline in Total Iron at Week 24
Timepoint [12] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [13] 0 0
Change From Baseline in Total Iron Binding Capacity at Week 24
Timepoint [13] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [14] 0 0
Change From Baseline in Reticulocyte Hemoglobin at Week 24
Timepoint [14] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [15] 0 0
Change From Baseline in Hematocrit at Week 24
Timepoint [15] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [16] 0 0
Change From Baseline in Red Blood Cells at Week 24
Timepoint [16] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [17] 0 0
Change From Baseline in Reticulocyte Count at Week 24
Timepoint [17] 0 0
Baseline (Day 1) and Week 24

Eligibility
Key inclusion criteria
- - Subjects are eligible if they meet all of the inclusion criteria below:

- General 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 [in questionable cases a blood sample with simultaneous follicle
stimulating hormone (FSH) 23.0-116.3 International units per liter (IU/L) and
estradiol <=10 picomole per liter (pmol/L) is confirmatory]. 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. For most forms of HRT, at least 2
weeks must elapse between the cessation of therapy and the blood draw; this interval
depends on the type and dosage of HRT. Following confirmation of their post-menopausal
status, they can resume use of HRT during the study without use of a contraceptive
method;

- Q-T Interval Corrected for Heart Rate (QTc): Bazett's Correction of QT Interval (QTcB)
<470 millisecond (msec) or QTcB <480 msec in subjects with bundle branch block. There
is no QTc inclusion criterion for a subject with a predominantly paced rhythm.

- CKD-related criteria

- Dialysis frequency: On hemodialysis (HD) three to five times weekly for at least 4
weeks prior to Week -4 Screening through Week 4. NOTE: Combination methods including
hemofiltration (HF) or ultrafiltration (UF) with HD are allowed. However, the type of
dialysis (HD, hemodiafiltration (HDF) or UF) should not change during the study.

- Dialysis adequacy: A single-pool dialyzer clearance multiplied by dialyzer time
divided by volume of distribution of urea (Kt/Vurea) of >=1.2 based on a historical
value obtained within the prior month in order to ensure the adequacy of dialysis. If
Kt/Vurea is not available, then an average of the last 2 values of urea reduction
ratio (URR) of at least 65%. NOTE: Only needs confirming at Week -4.

- Hemoglobin: Baseline Hgb of 9.0-11.5 g/dL (may rescreen in a minimum of 2 weeks).

- Stable rhEPO dose: Using the same rhEPO (epoetins or their biosimilars, or
darbepoetin) with total weekly doses varying 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.

- Iron replacement therapy: Subjects may be on stable maintenance oral or IV (<=100
mg/week) iron supplementation. If subjects are on oral or IV iron, then doses must be
stable for the 4 weeks prior to Week -4, during the screening phase, and through the
first 4 weeks after Randomization.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects are not eligible if they meet any of the exclusion criteria below:

- CKD-related criteria

- Dialysis modality: Planned change from HD to peritoneal dialysis within the study time
period.

- Renal transplant: Pre-emptive or scheduled renal transplant.

- High rhEPO dose: An epoetin dose of >=360 IU/Kg/Week IV or >=250 IU/kg/week
subcutaneous (SC) or darbepoetin dose of >=1.8 microgram (µg)/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).

- Laboratory test-based criteria (Week -4 verification only)

- Vitamin B12: At or below the lower limit of the reference range (may rescreen in a
minimum of 8 weeks).

- Folate: <2.0 nanogram (ng)/mL (<4.5 nanomole (nmol)/L) (may rescreen in a minimum of 4
weeks).

- Ferritin: <100 ng/mL (<100 Micrograms per liter).

- Transferrin saturation (TSAT): Outside of the reference range.

- Cardiovascular disease-related criteria

- 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).

- Hypertension: Defined using pre-dialysis vitals (Week -4, Day 1) of diastolic blood
pressure (DBP) >100 millimeters of mercury (mmHg) or systolic blood pressure (SBP)
>170 mmHg.

- 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).

- Other disease-related criteria

- 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. NOTE: Those with Hepatitis B or Hepatitis C
are eligible provided these exclusions are not met.

- 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.

- 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 intravenous (IV) antibiotic therapy within the 8 weeks prior to Week -4
Screening through Day 1 (randomization). NOTE: IV antibiotics as prophylaxis are
allowed.

- 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).

- Concomitant medication and other Investigational Product-related criteria

- Severe allergic reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product.

- 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).

- General health-related criteria

- Other Conditions: Any other condition, clinical or laboratory abnormality, or
examination finding that the Investigator considers would put the subject at
unacceptable risk.

- Pregnancy or Lactation: Pregnant females as determined by positive serum human
chorionic gonadotropin (hCG) test OR women who are lactating at Week -4 Screening or
during the trial.

- Other Eligibility Criteria Considerations

- Laboratory eligibility criteria will be assessed according to the central laboratory
results for the screening samples.

- Subjects who fail screening may be rescreened as soon as the investigator feels they
may have become eligible. However, an individual subject may not rescreen more than
twice. There is no predetermined amount of time that the investigator needs to wait to
rescreen a previously ineligible subject, except those excluded for Hgb or folate who
may only rescreen in 2 and 4 weeks, respectively, and those excluded for Vitamin B12
who may rescreen in 8 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/02/2015
Sample size
Target
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [4] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [5] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
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New York
Country [8] 0 0
United States of America
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North Carolina
Country [9] 0 0
United States of America
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Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
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Canada
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Quebec
Country [14] 0 0
Czechia
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Liberec
Country [15] 0 0
Czechia
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Louny
Country [16] 0 0
Czechia
State/province [16] 0 0
Most
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Czechia
State/province [17] 0 0
Praha 10
Country [18] 0 0
Czechia
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Praha 2
Country [19] 0 0
Czechia
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Praha 4
Country [20] 0 0
Czechia
State/province [20] 0 0
Sokolov
Country [21] 0 0
Denmark
State/province [21] 0 0
Odense C
Country [22] 0 0
Denmark
State/province [22] 0 0
Roskilde
Country [23] 0 0
France
State/province [23] 0 0
Amiens cedex 1
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux
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France
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Caen Cedex 9
Country [26] 0 0
France
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Paris Cedex 15
Country [27] 0 0
Germany
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Baden-Wuerttemberg
Country [28] 0 0
Germany
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Bayern
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Germany
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Mecklenburg-Vorpommern
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Hungary
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Budapest
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Hungary
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Esztergom
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Hungary
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Pécs
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Japan
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Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Kyoto
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Japan
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Niigata
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Japan
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Wakayama
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Japan
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Yamagata
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Korea, Republic of
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Anyang-Si Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Trondheim
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Norway
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Tønsberg
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Poland
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Krakow
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Poland
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Tarnow
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Poland
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Warszawa
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Poland
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Zabrze
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Russian Federation
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Kaluga
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Russian Federation
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Krasnodar
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Russian Federation
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Krasnogorsk
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Russian Federation
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Moscow
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Russian Federation
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Mytischi
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Alcala de Henares
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Spain
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Alicante
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Spain
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Almería
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Granada
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Spain
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Madrid
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Spain
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San Sebastian de los Reyes
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Spain
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Santander
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Spain
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Santiago de Compostela
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Sweden
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Karlstad
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Sweden
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Stockholm
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Sweden
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Uppsala
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Sweden
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Örebro
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United Kingdom
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Chelmsford
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United Kingdom
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Dorchester
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United Kingdom
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Dundee
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United Kingdom
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Hull
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United Kingdom
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London
Country [86] 0 0
United Kingdom
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Manchester
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is intended to evaluate the dose-response relationship of GSK1278863 over the
first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks
to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia
associated with chronic kidney disease (CKD) who are switched from a stable dose of
recombinant human erythropoietin (rhEPO). The data generated will enable selection of the
starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01977482
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01977482