Trial information
A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
Status: Recruiting
Protocol number: ML20977
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the maintenance of haemoglobin levels, safety and tolerability of monthly administration of intravenous Mircera in dialysis patients with chronic renal disease and anaemia who are currently receiving epoetin alfa or beta.
Brief summary: This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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: III
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. Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/L during evaluation period. Time frame: Weeks 17-24
Key secondary outcomes: 1. Change in Hb concentration over evaluation period Time frame: Weeks 17-24
2. Percentage of patients maintaining Hb concentration in target range throughout evaluation period. Time frame: Weeks 17-24
3. Mean time spent in Hb target range; mean number of months/subject requiring dose adjustments; incidence of RBC transfusions. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
- continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- hemolysis;
- folic acid and vitamin B12 deficiency.
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: 12/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Russian Federation
- Ekaterinburg
- Kemerovo
- Krasnodar
- Moscow
- Novosibirsk
- Omsk
- St Petersburg
- Tomsk
- Volzhsky
