Status:
COMPLETED
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ye...
Eligibility Criteria
Inclusion
- adult patients \>=18 years of age;
- type 1 or type 2 diabetes;
- stable glycemic control for \>=3 months;
- diabetic nephropathy.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00354341
Start Date
September 1 2002
End Date
July 1 2005
Last Update
March 31 2016
Active Locations (63)
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1
Linz, Austria, 4020
2
São Paulo, Brazil, 04038-002
3
Jihlava, Czechia, 586 33
4
Liberec, Czechia, 460 63