Phase 3
N=170
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00354341 ↗Enrolled (actual)
170
Serious AEs
24.1%
Results posted
Mar 2016
Primary outcome: Primary: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 — 0.69; 0.10 g/m^2 — p=0.8811
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Epoetin beta (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2005
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 |
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.
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). 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.