Trial information
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease Not Treated With ESA or on Dialysis.
Status: Recruiting
Protocol number: ML20888
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the safety, tolerability and effect on hemoglobin correction of monthly subcutaneous Mircera in patients with chronic kidney disease not currently treated with ESA and not on dialysis.
Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in patients with chronic kidney disease who are not treated with ESA and not on dialysis. Eligible patients will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
300.
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 Hb within range during evaluation period; change in Hb from baseline to evaluation period; mean time spent in target range Time frame: Weeks 29-36
Key secondary outcomes: 1. Incidence of RBC transfusions Time frame: Throughout study
2. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- baseline Hb between 9 and 11g/dL.
Exclusion criteria:
- prior ESA therapy during previous 3 months;
- acute or chronic bleeding requiring therapy during previous 2 months;
- transfusion of red blood cells during previous 2 months;
- active malignant disease (except non-melanoma skin cancer).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2007
Trial registration date: 11/14/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Arnsberg
- Bad Aibling
- Bad Malente
- Berlin
- Bischofswerda
- Bonn
- Dieburg
- Dortmund
- Düsseldorf
- Emsdetten
- Frankfurt
- Friedberg
- Grimma
- Hamburg
- Heidelberg
- Hilden
- Homburg
- Hoyerswerda
- Jena
- Kaiserslautern
- Koeln
- Köln
- Lörrach
- Lübeck
- Ludwigslust
- Lünen
- Mainz
- Mettmann
- Mühlacker
- München
- Regensburg
- Rheine
- Saarlouis
- Schwandorf
- Schweinfurt
- Sindelfingen
- Sinsheim
- Tangermünde
- Trier
- Tübingen
- Ulm
- Velbert
- Wetzlar
- Worms
- Wuerzburg
- Zwickau
