Trial information
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients.
Status: Recruiting
Protocol number: ML20978
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the effect on anemia correction, maintenance of haemoglobin levels, safety and tolerability of monthly administration of subcutaneous Mircera in pre-dialysis patients with chronic renal anemia not currently treated with ESA.
Brief summary: This single arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a recommended starting 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: 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. Change in Hb concentration between screening and evaluation period Time frame: Weeks 29-36
Key secondary outcomes: 1. Percentage of patients maintaining average Hb concentration of 11.0-13.0g/dL throughout evaluation period. Time frame: Weeks 29-36
2. Mean time spent in target Hb range; mean number of months/subject requiring any dose adjustment; RBC transfusions. Time frame: Throughout study
3. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia, with no need for dialysis expected in next 3 months;
- adequate iron status.
Exclusion criteria:
- previous epoetin therapy within 12 weeks prior to treatment;
- transfusion of red blood cells during 2 months prior to screening;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- hemolysis;
- folic acid and vitamin B 12 deficiency.
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: 12/17/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Russian Federation
- Ekaterinburg
- Irkutsk
- Khabarovsk
- Khanty-Mansiysk
- Moscow
- Nizhny Novgorod
- Omsk
- Orenburg
- Rostov-Na-Donu
- Saratov
- St Petersburg
- Tjumen
- Ufa
