Trial information
A Study of Subcutaneous Mircera, Versus no ESA Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant.
Status: Recruiting
Protocol number: MH21299
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to evaluate the effect of subcutaneous Mircera, versus no ESA therapy, on hemoglobin levels in chronic kidney disease patients with anemia after kidney transplant.
Brief summary: This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 318.
Study phase: IV
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. Change in Hb concentration between baseline and efficacy evaluation period (EEP). Time frame: Weeks 13-16
Key secondary outcomes: 1. Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions. Time frame: Throughout study
2. SF36 Time frame: Weeks 16 and 48
3. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- kidney transplant >=6 months and <5 years prior to randomization;
- anemia;
- no ESA therapy during 3 months prior to randomization.
Exclusion criteria:
- requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;
- change in Hb concentration >=1.5g/dL during screening period;
- transfusion of red blood cells during 3 months prior to randomization;
- poorly controlled hypertension;
- significant acute or chronic bleeding within 3 months prior to randomization.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 12/17/2007
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Poland
- Gdansk
- Poznan
- Szczecin
- Warszawa
- Wroclaw
United Kingdom
