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

This study has been completed.

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00354341

Purpose

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.

Condition	Intervention	Phase
Anemia	Drug: epoetin beta [NeoRecormon]	Phase III

MedlinePlus related topics: Anemia Diabetic Kidney Problems

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Efficacy: Left ventricular mass index

Secondary Outcome Measures:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354341

Show 63 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Principal Investigator:

Ebenhard Ritz, Prof. Dr.

unaffliated

More Information

Publications indexed to this study:

Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger U, de Alvaro F; Anemia Correction in Diabetes Study Investigators. Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study. Am J Kidney Dis. 2007 Feb;49(2):194-207. Erratum in: Am J Kidney Dis. 2007 Apr;49(4):562.

Study ID Numbers:	MA16620
Study First Received:	July 19, 2006
Last Updated:	July 19, 2006
ClinicalTrials.gov Identifier:	NCT00354341
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Epoetin Alfa
Diabetic Nephropathies
Urologic Diseases
Hematologic Diseases
Diabetes Mellitus

Anemia
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on January 14, 2009