Trial information
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for the Maintenance Treatment of Anemia in Kidney Transplant Recipients.
Status: Recruiting
Protocol number: ML21058
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 subcutaneous C.E.R.A. versus darboepoetin alfa for the maintenance of haemoglobin levels in renal transplant recipients with chronic renal anaemia.
Brief summary: This 2 arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms sc) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. 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: Week 17-24
Key secondary outcomes: 1. Change in Hb concentration, and percentage of patients maintaining Hb concentration in 10-12 g/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;
- kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
- functioning graft of >6 months and <10 years after kidney transplantation, with no signs of acute rejection;
- stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- need for dialysis therapy expected in next 6 months.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2008
Trial registration date: 01/16/2008
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Spain
- Alicante
- Badajoz
- Badalona
- Barcelona
- Bilbao
- Ciudad Real
- Córdoba
- Galdakao
- La Coruna
- Madrid
- Santander
- Santiago de Compostela
- Valencia
- Valladolid
