Trial information
MISTRAL Study: A Study of Monthly Subcutaneous Mircera for Maintenance Treatment of Patients With Chronic Kidney Disease on Peritoneal Dialysis.
Status: Not yet recruiting
Protocol number: ML21421
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A single arm, open-label, multi-center study to assess the maintenance of haemoglobin levels with once monthly subcutaneous Mircera in patients with chronic kidney disease on peritoneal dialysis
Brief summary: This single arm study will assess the efficacy and safety of monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic kidney disease on peritoneal dialysis. Patients currently receiving maintenance treatment with subcutaneous ESA will receive monthly subcutaneous injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving. 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. Percentage of patients maintaining average Hb concentration within range of 10-12g/dL during Efficacy Evaluation Period (EEP). Time frame: Weeks 16-24
Key secondary outcomes: 1. Percentage of patients maintaining all Hb concentrations within range of 10-12g/dL during EEP. Time frame: Weeks 16-24
2. Percentage of patients maintaining average Hb concentration within range of 10-12g/dL, and with Hb variation <= +/- 1.0g/dL compared to baseline. Time frame: Weeks 16-52
3. Mean change in Hb concentration; dose adjustments; RBC transfusions Time frame: Throughout study
4. Mean time spent in Hb range of 10-12g/dL Time frame: Weeks 16-52
5. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic kidney disease, on peritoneal dialysis for >3 months;
- chronic renal anemia;
- continuous s.c. maintenance stable ESA therapy for 4 weeks prior to study start.
Exclusion criteria:
- transfusion of red blood cells during previous 8 weeks;
- poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months;
- significant acute or chronic bleeding during previous 8 weeks.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2008
Trial registration date: 08/15/2008
Date last updated: 11/21/2008
Link to trial result
This trial will be conducted at the following locations:
France
- Annonay
- Arras
- Auxerre
- Besancon
- Beuvry
- Bordeaux
- Brest
- Cabestany
- Caen
- Cannes
- Chalon Sur Saone
- Chambery
- Charleville Mezieres
- Chartres
- Cherbourg Octeville
- Colmar
- Creil
- Dijon
- Dunkerque
- Evreux
- La Tronche
- Le Petit Quevilly
- Lille
- Lisieux
- Lyon
- Melun
- Mulhouse Cedex 1
- Nantes
- Niort
- Orleans
- Paris
- Poitiers
- Pontoise
- Quimper
- Reims
- Saint Lo
- Saint Ouen
- Saint-Denis
- Saintes
- Saint-Maurice
- Saint-Pierre
- St Nazaire
- St Priest En Jarez
- Strasbourg
- Tours
- Valence
- Vandoeuvre Les Nancy
- Vannes
