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

Anemia Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00440063
• Other study ID #: ML20828
• Status: Terminated
• Phase: Phase 4
• First received: February 23, 2007
• Last updated: December 18, 2007

Study information

• Verified date: December 2007
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• epoetin beta [NeoRecormon]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving target Hb within 20 weeks.
Secondary	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.