Clinical trial NCT00642967: A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period
timeFrame: Weeks 16-24
Secondary outcomes:
measure: Mean change in Hb concentration
timeFrame: Between reference and Efficacy Evaluation Period
measure: Mean time spent in Hb range
timeFrame: Weeks 16-24
measure: % patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions
timeFrame: Weeks 16-48
measure: AEs, lab parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Aix En Provence
country: France
city: Angers
country: France
city: Angers
country: France
city: Annonay
country: France
city: Avignon
country: France
city: Bastia
country: France
city: Beauvais
country: France
city: Besancon
country: France
city: Bois-guillaume
country: France
city: Bordeaux
country: France
city: Boulogne Sur Mer
country: France
city: Bourg En Bresse
country: France
city: Bourges
country: France
city: Brest
country: France
city: Caen
country: France
city: Chalon Sur Saone
country: France
city: Chartres
country: France
city: Cherbourg Octeville
country: France
city: Cholet
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Creil
country: France
city: Creteil
country: France
city: Dieppe
country: France
city: Evreux
country: France
city: Greize
country: France
city: Harfleur
country: France
city: La Garenne-colombes
country: France
city: La Tronche
country: France
city: Le Havre
country: France
city: Le Mans
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Maubeuge
country: France
city: Metz Tessy
country: France
city: Metz
country: France
city: Montlucon
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Nancy
country: France
city: Nice
country: France
city: Nimes
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Poitiers
country: France
city: Quimper
country: France
city: Roubaix
country: France
city: Saint Laurent Du Var
country: France
city: Saint Lo
country: France
city: Saint-malo
country: France
city: Saint-michel
country: France
city: Salouel
country: France
city: Sens
country: France
city: St Brieuc
country: France
city: St Nazaire
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Thionville
country: France
city: Toulouse
country: France
city: Tournan-en-brie
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: