A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

Roche

Status and phase: Terminated; Phase 4

Conditions: Anemia

Treatments: Drug: epoetin beta [NeoRecormon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440063

ML20828

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)