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
Show all queries
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00394953
Registration number
NCT00394953
Ethics application status
Date submitted
1/11/2006
Date registered
2/11/2006
Date last updated
20/01/2017
Titles & IDs
Public title
A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
Query!
Scientific title
A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis
Query!
Secondary ID [1]
0
0
BH17847
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Anemia
0
0
Query!
Condition category
Condition code
Blood
0
0
0
0
Query!
Anaemia
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Darbepoetin alfa
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta [Mircera]
Experimental: MIRCERA - Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Active Comparator: Darbepoetin Alfa - Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Treatment: Drugs: Darbepoetin alfa
As prescribed, iv.
Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv / month, starting dose
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period
Query!
Assessment method [1]
0
0
Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.
Query!
Timepoint [1]
0
0
Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)
Query!
Secondary outcome [1]
0
0
Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time
Query!
Assessment method [1]
0
0
All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.
Query!
Timepoint [1]
0
0
Week 27 to Month 12
Query!
Secondary outcome [2]
0
0
Number of Participants With Marked Laboratory Abnormality Over Time
Query!
Assessment method [2]
0
0
Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.
Query!
Timepoint [2]
0
0
Up to Week 53
Query!
Secondary outcome [3]
0
0
Median Blood Pressure Over Time
Query!
Assessment method [3]
0
0
Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.
Query!
Timepoint [3]
0
0
Baseline (Week -4 to Week -1), Week 28, and Week 52
Query!
Secondary outcome [4]
0
0
Mean Pulse Rate Over Time
Query!
Assessment method [4]
0
0
Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.
Query!
Timepoint [4]
0
0
Baseline (Week -4 to Week -1), Week 28, and Week 52
Query!
Secondary outcome [5]
0
0
Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths
Query!
Assessment method [5]
0
0
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.
Query!
Timepoint [5]
0
0
From screening to Week 56
Query!
Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;
- chronic renal anemia;
- hemodialysis 3 times weekly for >=12 weeks before screening, and during
screening/baseline period;
- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and
during screening/baseline period.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- overt gastrointestinal bleeding within 8 weeks before screening or during
screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening or during
screening/baseline period;
- active malignancy;
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
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
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
1/12/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
490
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Clayton
Query!
Recruitment hospital [3]
0
0
- Gosford
Query!
Recruitment hospital [4]
0
0
- Parkville
Query!
Recruitment hospital [5]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
SA 5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3186 - Clayton
Query!
Recruitment postcode(s) [3]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [4]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Linz
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Wien
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Aalst
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Bruxelles
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Roeselare
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Alberta
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Ontario
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Quebec
Query!
Country [9]
0
0
Denmark
Query!
State/province [9]
0
0
Aalborg
Query!
Country [10]
0
0
Denmark
Query!
State/province [10]
0
0
Hillerød
Query!
Country [11]
0
0
Denmark
Query!
State/province [11]
0
0
Roskilde
Query!
Country [12]
0
0
Finland
Query!
State/province [12]
0
0
Tampere
Query!
Country [13]
0
0
Finland
Query!
State/province [13]
0
0
Turku
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Auch
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Bordeaux
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Boulogne
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Castelnau Le Lez
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Cergy Pontoise
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Chamalieres
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Dijon
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Fleury-merogis
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Herouville Saint Clair
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
La Tronche
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Lyon
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Montpellier
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Nimes
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Paris
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Reims
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Rennes
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Saint Herblain
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Saint Ouen
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
St Brieuc
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Villeurbanne
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Bad Hersfeld
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Bonn
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Dortmund
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
München
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Stuttgart
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Villingen-schwenningen
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Bologna
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Como
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Genova
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Lecco
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Modena
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Pavia
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Prato
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Venezia
Query!
Country [48]
0
0
Netherlands
Query!
State/province [48]
0
0
Amsterdam
Query!
Country [49]
0
0
Netherlands
Query!
State/province [49]
0
0
Dordrecht
Query!
Country [50]
0
0
Portugal
Query!
State/province [50]
0
0
Leiria
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Alicante
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Badalona
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Barcelona
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Bilbao
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Córdoba
Query!
Country [56]
0
0
Spain
Query!
State/province [56]
0
0
Leon
Query!
Country [57]
0
0
Spain
Query!
State/province [57]
0
0
Madrid
Query!
Country [58]
0
0
Spain
Query!
State/province [58]
0
0
Orense
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Santander
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Vigo
Query!
Country [61]
0
0
Switzerland
Query!
State/province [61]
0
0
Aarau
Query!
Country [62]
0
0
Switzerland
Query!
State/province [62]
0
0
Lausanne
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
Belfast
Query!
Country [64]
0
0
United Kingdom
Query!
State/province [64]
0
0
Canterbury
Query!
Country [65]
0
0
United Kingdom
Query!
State/province [65]
0
0
Glasgow
Query!
Country [66]
0
0
United Kingdom
Query!
State/province [66]
0
0
London
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Manchester
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Truro
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa,
administered at extended dosing intervals, in the maintenance treatment of anemia in patients
with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving
once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to
receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360
micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study)
or intravenous darbepoetin alfa every 2 weeks before switching to once monthly
administration. The anticipated time on study treatment is 3-12 months, and the target sample
size is 100-500 individuals.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00394953
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
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/NCT00394953
Download to PDF
Show all queries