A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

NCT ID: NCT00413101

Last Updated: 2009-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2008-03-31

Brief Summary

This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Conditions

Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

epoetin beta [NeoRecormon]

Intervention Type: DRUG

At a dose to achieve and maintain an Hb level of 120-135g/L

Interventions

epoetin beta [NeoRecormon]

At a dose to achieve and maintain an Hb level of 120-135g/L

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients, 18-75 years of age;
• end-stage renal disease;
• on renal dialysis >= 3 months;
• receiving NeoRecormon treatment >= 3 months;
• Hb stable and <105g/L, and LVMI >160g/m2.

Exclusion Criteria

• unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
• use of any ESA other than NeoRecormon;
• acute infection;
• use of iv NeoRecormon.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Hoffmann-La Roche

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Novi Sad, , Serbia

Countries

Serbia

Other Identifiers

ML20201

Identifier Type: -

Identifier Source: org_study_id