Trial information
A Study of Subcutaneous Mircera For The Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
Status: Recruiting
Protocol number: ML21146
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
Brief summary: This single arm study will assess the efficacy and safety of monthly administration of subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia, not on dialysis. Patients currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of Mircera, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of ESA previously administered. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
250.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta[Mircera]
Primary outcome: 1. Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period Time frame: Weeks 16-24
Key secondary outcomes: 1. Mean change in Hb concentration Time frame: Between reference and Efficacy Evaluation Period
2. Mean time spent in Hb range Time frame: Weeks 16-24
3. % patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions Time frame: Weeks 16-48
4. AEs, lab parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
- continuous stable subcutaneous maintenance ESA therapy during previous month.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding;
- poorly controlled hypertension.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2008
Trial registration date: 03/18/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Aix en Provence
- Amiens
- Angers
- Annonay
- Avignon
- Bastia
- Beauvais
- Besancon
- Bois-Guillaume
- Bordeaux
- Boulogne Sur Mer
- Bourg En Bresse
- Bourges
- Bourgoin Jallieu
- Brest
- Caen
- Cergy Pontoise
- Chalon Sur Saone
- Chartres
- Cherbourg Octeville
- Cholet
- Clermont-Ferrand
- Colmar
- Creil
- Creteil
- Dieppe
- Evreux
- Greize
- Harfleur
- La Garenne-Colombes
- La Roche Sur Yon
- La Tronche
- Le Havre
- Le Kremlin-Bicetre
- Le Mans
- Lille
- Limoges Cedex 1
- Lorient
- Maubeuge
- Metz
- Metz Tessy
- Mont-De-Marsan
- Montlucon
- Montpellier
- Nancy
- Nice
- Nimes
- Niort
- Orleans
- Paris
- Pierre Benite
- Poitiers
- Quimper
- Roubaix Cedex 1
- Saint Brieuc
- Saint Laurent Du Var
- Saint Lo
- Saint-Michel
- Sens
- St Malo
- St Nazaire
- Strasbourg
- Suresnes
- Thionville
- Toulouse
- Tournan-En-Brie
- Valenciennes
- Vandoeuvre-Les-Nancy
- Vannes
