drugset / Trial / NCT00354341
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2002-09
- Primary completion
- 2005-07
- Completion
- 2005-07
Outcome
Missed primary endpoint
registry Group 1 (Early Epoetin Beta) vs Group 2 (No/Late Epoetin Beta); p = 0.8811; ANCOVA with LOCF NCT00354341 ↗
paper No significant differences were observed in median LVMI at month 15 between study groups (group 1, 112.3 g/m(2); group 2, 116.5 g/m(2)). PMID 17261422 ↗
Publications
- Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- 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. doi: 10.1053/j.ajkd.2006.11.032.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 2000 iu | Subcutaneous |