A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients

November 23, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, SA 5000
      • Clayton, Australia, 3186
      • Gosford, Australia, 2250
      • Parkville, Australia, 3052
      • Woolloongabba, Australia, 4102
  • Austria
      • Linz, Austria, 4010
      • Wien, Austria, 1220
      • Wien, Austria, 1090
  • Belgium
      • Aalst, Belgium, 9300
      • Bruxelles, Belgium, 1020
      • Bruxelles, Belgium, 1200
      • Roeselare, Belgium, 8800
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • Kitchener, Ontario, Canada, N2G 1N9
      • Mississauga, Ontario, Canada, L5M 2V8
      • Ottawa, Ontario, Canada, K1H 7W9
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Trois-rivieres, Quebec, Canada, G8Z 4K8
  • Denmark
      • Aalborg, Denmark, 9100
      • Hillerød, Denmark, 3400
      • Roskilde, Denmark, 4000
  • Finland
      • Tampere, Finland, 33521
      • Turku, Finland, 20521
  • France
      • Auch, France, 32000
      • Bordeaux, France, 33000
      • Boulogne, France, 62321
      • Castelnau Le Lez, France, 34170
      • Cergy Pontoise, France, 95303
      • Chamalieres, France, 63400
      • Dijon, France, 21079
      • Fleury-merogis, France, 91712
      • Herouville Saint Clair, France, 14202
      • La Tronche, France, 38701
      • Lyon, France, 69437
      • Montpellier, France, 34295
      • Nimes, France, 30029
      • Paris, France, 75970
      • Paris, France, 75015
      • Reims, France, 51092
      • Rennes, France, 35033
      • Saint Herblain, France, 44093
      • Saint Ouen, France, 93400
      • St Brieuc, France, 22027
      • Villeurbanne, France, 69100
  • Germany
      • Bad Hersfeld, Germany, 36251
      • Bonn, Germany, 53127
      • Dortmund, Germany, 44263
      • München, Germany, 80804
      • Stuttgart, Germany, 70191
      • Villingen-schwenningen, Germany, 78054
  • Italy
      • Bologna, Italy, 40138
      • Como, Italy, 22100
      • Genova, Italy, 16132
      • Lecco, Italy, 23900
      • Modena, Italy, 41100
      • Pavia, Italy, 27100
      • Prato, Italy, 50047
      • Venezia, Italy, 30122
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
      • Dordrecht, Netherlands, 3318 AT
  • Portugal
      • Leiria, Portugal, 2400-441
  • Spain
      • Alicante, Spain, 03010
      • Badalona, Spain, 08915
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Bilbao, Spain, 48013
      • Córdoba, Spain, 14004
      • Leon, Spain, 24071
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
      • Madrid, Spain, 28222
      • Madrid, Spain, 28035
      • Madrid, Spain, 28003
      • Orense, Spain, 32005
      • Santander, Spain, 39008
      • Vigo, Spain, 36204
      • Vigo, Spain, 36205
  • Switzerland
      • Aarau, Switzerland, 5001
      • Lausanne, Switzerland, 1003
  • United Kingdom
      • Belfast, United Kingdom, BT9 7LJ
      • Canterbury, United Kingdom, CT1 3NE
      • Glasgow, United Kingdom, G4 OSF
      • London, United Kingdom, SE22 8PT
      • Manchester, United Kingdom, M13 9WL
      • Truro, United Kingdom, TR1 3LJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv / month, starting dose
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.
Drug: Darbepoetin alfa
As prescribed, iv.
Other Names:
  • Aranesp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)
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.
Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time
Time Frame: Week 27 to Month 12
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.
Week 27 to Month 12
Number of Participants With Marked Laboratory Abnormality Over Time
Time Frame: Up to Week 53
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.
Up to Week 53
Median Blood Pressure Over Time
Time Frame: Baseline (Week -4 to Week -1), Week 28, and Week 52
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.
Baseline (Week -4 to Week -1), Week 28, and Week 52
Mean Pulse Rate Over Time
Time Frame: Baseline (Week -4 to Week -1), Week 28, and Week 52
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.
Baseline (Week -4 to Week -1), Week 28, and Week 52
Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths
Time Frame: From screening to Week 56
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.
From screening to Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 1, 2006

First Submitted That Met QC Criteria

November 1, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH17847

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe