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

NCT00642967

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Anemia

Interventions: Methoxy Polyethylene Glycol-epoetin Beta

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (69)

Aix-en-Provence, France
Angers, France
Angers, France
Annonay, France
Avignon, France
Bastia, France
Beauvais, France
Besançon, France
Bois-Guillaume, France
Bordeaux, France
Boulogne-sur-Mer, France
Bourg-en-Bresse, France
Bourges, France
Brest, France
Caen, France
Chalon-sur-Saône, France
Chartres, France
Cherbourg Octeville, France
Cholet, France
Clermont-Ferrand, France
Colmar, France
Creil, France
Créteil, France
Dieppe, France
Évreux, France
Greize, France
Harfleur, France
La Garenne-Colombes, France
La Tronche, France
Le Havre, France
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