Overview
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
Status:
Terminated
Terminated
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Epoetin Alfa
Criteria
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.