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

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00354341

MA16620

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Group 1 (Early Epoetin Beta)

Experimental group

Description:

Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion.

Treatment:

Drug: Epoetin beta

Group 2 (No/Late Epoetin Beta)

Active Comparator group

Description:

Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (\<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be \<10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion.

Treatment:

Drug: Epoetin beta