An open-label, randomized, multicenter, parallel group study to demonstrate correction of anemia using intravenous injections of RO0503821 in patients with chronic kidney disease who are on dialysis
Phase 1
- Conditions
- anemia in chronic kidney patients who are in dialysis
- Registration Number
- EUCTR2004-001298-24-ES
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 168
Inclusion Criteria
Baseline predialysis (for HD patients) Hb concentration 8-11 g/dL determined from the mean of 2 screening values with at least one day between measurements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Previous therapy with recombinant human erythropoetin or any other erythropoeitc substance within 12 weeks prior to screening. If epoetin treatment has been interrupted for at least 12 weeks, the patient may be enrolled in the study. Ongoing epoetin treatment should not be discontinued to allow participation in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method