Trial information
A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
Status: Completed
Protocol number: BA16286
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of dose conversion factors for maintenance subcutaneous Mircera in dialysis patients with chronic renal anemia
Brief summary: This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Target sample size is 135.
Study phase: II
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 hemoglobin from baseline over time under constant dosing regimen
Time frame: Throughout study
Key secondary outcomes: 1. Change in hematocrit from baseline over time under constant dosing regimen.
Vital signs, adverse events, laboratory values
Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
- receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.
Exclusion criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Berlin
- Mannheim
- Villingen-Schwenningen
- Wiesloch
Italy
- Bari
- Bergamo
- Lecco
- Lodi
- Milano
- Modena
- Pavia
- Vicenza
Spain
- Barcelona
- Madrid
- Malaga
- Santander
United States
- Los Angeles, CA
- San Jose, CA
- Boston, MA
- Cleveland, OH
- Houston, TX
- Morgantown, WV
