Trial information
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Status: No longer recruiting
Protocol number: ML20572
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the effect of intravenous Mircera on hemoglobin levels in anemic patients with chronic kidney disease who are on dialysis, and who have previously received epoetin alfa or beta or darbepoetin alfa treatment.
Brief summary: This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 600.
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 in a defined Hb range and percentage of patients with or without dose adjustments, during evaluation period. Time frame: Weeks 17-24
Key secondary outcomes: 1. Percentage of patients in a defined Hb range, and percentage of patients with or without dose adjustments. Time frame: During screening period
2. Incidence of RBC transfusions Time frame: Weeks 0-24
3. AEs, laboratory parameters, vital signs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- longterm hemodialysis for >=12 weeks before screening;
- baseline Hb between 10 and 13g/dL;
- iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.
Exclusion criteria:
- acute or chronic bleeding within 8 weeks prior to screening;
- transfusion of red blood cells within 8 weeks prior to screening;
- poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
- previous treatment with Mircera.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2007
Trial registration date: 12/19/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Aachen
- Alzey
- Ansbach
- Augsburg
- Bad König
- Bad Neundorf
- Bad Orb
- Bayreuth
- Berlin
- Bochum
- Bottrop
- Bovenden
- Braunschweig
- Bremen
- Coesfeld
- Darmstadt
- Daun
- Demmin
- Dessau
- Dortmund
- Düsseldorf
- Erfurt
- Essen
- Frankfurt Am Main
- Freiburg
- Freudenstadt
- Fulda
- Fürstenzell
- Fürth
- Gelsenkirchen
- Gerolstein
- Giessen
- Göttingen
- Greifswald
- Gütersloh
- Hamburg
- Hann. Münden
- Hannover
- Harsewinkel
- Heide
- Heidelberg
- Heilbronn
- Homburg
- Idar-Oberstein
- Jena
- Karlsruhe
- Kiel
- Köln
- Lauterbach
- Leipzig
- Lüdenscheid
- Ludwigsburg
- Ludwigshafen
- Marburg
- Marl
- Meiningen
- Minden
- Mönchengladbach
- München
- Neuruppin
- Oberschleissheim
- Offenbach
- Offenburg
- Potsdam
- Reutlingen
- Ribnitz-Damgarten
- Rostock
- Saarbrücken
- Schloss Holte-Stutenbrock
- Schwerin
- Schwetzingen
- Stralsund
- Stuttgart
- Trier
- Waiblingen
- Weinheim
- Wiesbaden
- Wiesloch
- Wuppertal
- Würzburg
