A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

September 9, 2021 updated by: Hoffmann-La Roche

A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

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

  • France
      • Aix En Provence, France, 13090
      • Angers, France, 49933
      • Angers, France, 49000
      • Annonay, France, 07103
      • Avignon, France, 84902
      • Bastia, France, 20604
      • Beauvais, France, 60000
      • Besancon, France, 25030
      • Bois-guillaume, France, 76233
      • Bordeaux, France, 33077
      • Boulogne Sur Mer, France, 62321
      • Bourg En Bresse, France, 01012
      • Bourges, France, 18020
      • Brest, France, 29609
      • Caen, France, 14033
      • Chalon Sur Saone, France, 71100
      • Chartres, France, 28000
      • Cherbourg Octeville, France, 50102
      • Cholet, France, 49300
      • Clermont-ferrand, France, 63058
      • Colmar, France, 68024
      • Creil, France, 60100
      • Creteil, France, 94010
      • Dieppe, France, 76202
      • Evreux, France, 27023
      • Greize, France, 69400
      • Harfleur, France, 76700
      • La Garenne-colombes, France, 92250
      • La Tronche, France, 38701
      • Le Havre, France, 76083
      • Le Mans, France, 72037
      • Lille, France, 59042
      • Limoges, France, 87042
      • Lyon, France, 69437
      • Maubeuge, France, 59604
      • Metz, France, 57045
      • Metz Tessy, France, 74370
      • Montlucon, France, 03108
      • Montpellier, France, 34295
      • Montpellier, France, 34097
      • Nancy, France, 54100
      • Nice, France, 06002
      • Nimes, France, 30006
      • Orleans, France, 45000
      • Paris, France, 75018
      • Paris, France, 75970
      • Paris, France, 75743
      • Paris, France, 75908
      • Paris, France, 75651
      • Pierre Benite, France, 69495
      • Poitiers, France, 86021
      • Quimper, France, 29000
      • Roubaix, France, 59056
      • Saint Laurent Du Var, France, 06721
      • Saint Lo, France, 50009
      • Saint-malo, France, 35043
      • Saint-michel, France, 16470
      • Salouel, France, 80480
      • Sens, France, 89108
      • St Brieuc, France, 22027
      • St Nazaire, France, 44606
      • Strasbourg, France, 67091
      • Suresnes, France, 92151
      • Thionville, France, 57126
      • Toulouse, France, 31059
      • Tournan-en-brie, France, 77220
      • Valenciennes, France, 59300
      • Vandoeuvre-les-nancy, France, 54511
      • Vannes, France, 56017

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:

  • chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
  • continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • significant acute or chronic bleeding;
  • poorly controlled hypertension.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methoxy Polyethylene Glycol-epoetin Beta
Participants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Drug: Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Other Names:
  • Mircera
  • C.E.R.A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period
Time Frame: Weeks 16-24
Weeks 16-24

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs, lab parameters
Time Frame: Throughout study
Throughout study
Mean change in Hb concentration
Time Frame: Between reference and Efficacy Evaluation Period
Between reference and Efficacy Evaluation Period
Mean time spent in Hb range
Time Frame: Weeks 16-24
Weeks 16-24
% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions
Time Frame: Weeks 16-48
Weeks 16-48

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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

June 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21146
  • 2007-005757-28 (EudraCT Number)

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.

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