Trial information
A Study of Intravenous Mircera for the Maintenance Treatment of Hemodialysis Patients With Chronic Renal Anemia
Status: Recruiting
Protocol number: ML21060
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label randomised controlled study to compare the efficacy, safety and tolerability of once-monthly administration of intravenous C.E.R.A. versus epoetin alfa for the maintenance of haemoglobin levels in dialysis patients with chronic renal anaemia
Brief summary: This 2 arm study will compare the efficacy and safety of monthly administration of intravenous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 297.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; 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 +/- 1g/dL of reference Hb, and between 10-12g/dL during evaluation period. Time frame: Weeks 17-24
Key secondary outcomes: 1. Change in Hb concentration, and percentage of patients maintaining Hb concentration in 10-12g/dL range. Time frame: Weeks 17-24
2. Mean time in 10-12g/dL range; percentage of patients needing dose adjustments; incidence of RBC transfusions. Time frame: Throughout study
3. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >= 18 years of age;
- chronic renal anemia;
- continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the 2 months before screening;
- regular hemodialysis for >=3 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;
- significant acute or chronic bleeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2008
Trial registration date: 01/16/2008
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
Spain
- Badajoz
- Barcelona
- Caceres
- Castellon
- Ciudad Real
- Huelva
- Madrid
- Marbella
- Pontevedra
- Salamanca
- Teruel
- Tudela
- Valencia
- Zamora
- Zaragoza
