A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
Phase 4
Terminated
- Conditions
- Anemia
- Registration Number
- NCT00440063
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- adult patients, 18-80 years of age;
- stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
- Hb <100g/L, TSAT>=20%, and ferritin >=100 mcg/L at screening.
Exclusion Criteria
- anticipating to go on renal replacement therapy;
- anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
- uncontrolled hypertension;
- congestive heart failure;
- active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of patients achieving target Hb within 20 weeks.
- Secondary Outcome Measures
Name Time Method Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs.