Trial information
A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Status: Recruiting
Protocol number: ML21208
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the effect of once monthly administration of subcutaneous Mircera versus epoetin alfa on maintenance of hemoglobin levels, safety and tolerability in dialysis patients with chronic renal anemia.
Brief summary: This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) 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
262.
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 target range during evaluation period Time frame: Weeks 29-36
Key secondary outcomes: 1. Percentage of patients maintaining Hb concentration in target range during evaluation period Time frame: Weeks 29-36
2. Changes in Hb concentration over evaluation period, and average time elapsed within target range Time frame: Weeks 29-36
3. Incidence of RBC transfusions Time frame: Throughout study
4. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- regular hemodialysis with the same schedule of dialysis for >=12 weeks;
- maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
- acute or chronic bleeding;
- 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: April, 2008
Trial registration date: 11/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Brazil
- Belo Horizonte
- Brasilia
- Campinas
- Campo Grande
- Cariacica
- Curitiba
- Fortaleza
- Jaboatão Dos Guararapes
- Joinville
- Juiz De Fora
- Londrina
- Natal
- Porto Alegre
- Ribeirão Preto
- Rio De Janeiro
- Salvador
- Sao Jose do Rio Preto
- Sao Luis
- Sao Paulo
- Sorocaba
