Trial Information

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

Status: Completed

Protocol Number: MA16620

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of anemia correction with NeoRecormon on cardiac structure and function in anemic patients with early diabetic nephropathy.

Brief 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. Target sample size is 160.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Anemia

Intervention Type: Drug

Intervention Name: epoetin beta[NeoRecormon]

Primary Outcome: 1. Efficacy: Left ventricular mass index

Key Secondary Outcomes: 1. Efficacy: LVESVI, LVEDVI, left ventricular ejection fraction, fractional shortening, % patients with stable hemoglobin levels between 13-15 g/dL. Safety: Adverse events, lab parameters, vital signs.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:19:10 PM