Trial information
A Study of Subcutaneous Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia Not Receiving ESA Treatment or Dialysis.
Status: Recruiting
Protocol number: ML21348
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the safety, tolerability and effect on hemoglobin levels of monthly subcutaneous Mircera in patients with chronic kidney disease not treated with ESA or dialysis.
Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction and/or maintenance of hemoglobin levels in chronic kidney disease patients with renal anemia, who are not currently treated with ESA or on dialysis. Eligible patients will receive monthly subcutaneous injections of Mircera, at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 200.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Proportion of patients maintaining average hemoglobin concentration during Efficacy Evaluation Period (EEP)within target range Time frame: Weeks 29-36
Key secondary outcomes: 1. Change in hemoglobin concentration between baseline and EEP Time frame: Weeks 1-28
2. Proportion of patients maintaining hemoglobin concentrations within range of 10-12g/dL throughout EEP Time frame: Weeks 29-36
3. Mean time spent in hemoglobin range of 10-12g/dL during EEP Time frame: Weeks 29-36
4. AEs, lab parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- no ESA therapy during previous 3 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization 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: Yes
Anticipated start date: June, 2008
Trial registration date: 03/18/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Belgium
- Aalst
- Antwerpen
- Assebroek
- Ath
- Baudour
- Bonheiden
- Bruxelles
- Charleroi
- Dendermonde
- Edegem
- Genk
- Gent
- Hornu
- Huy
- Ieper
- La Louvière
- Leuven
- Liege
- Liège
- Roeselare
- Sint Niklaas
- Tournai
- Turnhout
- Verviers
