Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
Status: Terminated
Protocol number: ML20828
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized study to compare the safety and effectiveness of two monitoring schedules to maintain hemoglobin levels and iron parameters in patients with renal anemia receiving NeoRecormon
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. Target sample size is
120.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta [NeoRecormon]
Primary outcome: 1. Percentage of patients achieving target Hb within 20 weeks.
Key secondary outcomes: 1. 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.
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.
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 02/23/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Liverpool
- Parkville
- Perth
- Tasmania
- Woollongabba
