(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• type 1 or type 2 diabetes;

• stable glycemic control for >=3 months;

• diabetic nephropathy.

Exclusion Criteria:

• women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;

• previous treatment with erythropoietin or other erythropoietic substance;

• nondiabetic renal disease, nephrotic syndrome;

• blood transfusion within the 3 months prior to enrollment;

• administration of any investigational drug within 30 days preceding the study start, and during the study.