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

Anemia Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354341
• Other study ID #: MA16620
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2006
• Last updated: July 19, 2006

Study information

• Verified date: July 2006
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Diabetic Nephropathies

Intervention

Drug:
• epoetin beta [NeoRecormon]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Brazil,  Czech Republic,  Denmark,  Finland,  Germany,  Greece,  Hungary,  Italy,  Mexico,  Poland,  Russian Federation,  Singapore,  Spain,  Sweden,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Left ventricular mass index
Secondary	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.