Phase 3
Completed N=170
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
Source: ClinicalTrials.gov NCT00354341 ↗Enrolled (actual)
170
Serious AEs
24.1%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 — 0.69; 0.10 g/m^2 — p=0.8811
◆ Published Evidence
Highly cited
▲ Trending
149citations · ~8 / year
Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study.
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.
Linked Publications (2)
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Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study.
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Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 |
0.69; 0.10 | 0.8811 |
| SECONDARY Left Ventricular End Systolic Volume Index (LVESVI) |
22.40; 21.04; 26.86; 24.54; 25.99; 25.03 | 0.8864 |
| SECONDARY Left Ventricular End Diastolic Volume Index (LVEDVI) |
61.08; 58.13; 62.74; 60.40; 62.26; 62.07 | 0.5681 |
| SECONDARY Fractional Myocardial Shortening (FS) |
36.45; 36.58; 37.80; 38.49; 37.58; 38.86 | 0.1578 |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
63.44; 63.84; 57.22; 59.92; 58.63; 59.97 | 0.2913 |
| SECONDARY Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL |
75.6; 9.9 | <0.001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00354341) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.