(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
- Registration Number
- NCT00354341
- Lead Sponsor
- Hoffmann-La Roche
- 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 years and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- adult patients >=18 years of age;
- type 1 or type 2 diabetes;
- stable glycemic control for >=3 months;
- diabetic nephropathy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 (No/Late Epoetin Beta) Epoetin beta Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (\<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be \<10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion. Group 1 (Early Epoetin Beta) Epoetin beta Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion.
- Primary Outcome Measures
Name Time Method Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 Baseline, Month 15 LVMI (in g/m\^2) = (0.8 \[1.04 {(LVEDD + IVS + PWT)\^3 - (LVEDD)\^3}\] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters \[cm\]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m\^2).
- Secondary Outcome Measures
Name Time Method Left Ventricular End Systolic Volume Index (LVESVI) Baseline, Months 6 and 15 LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters \[mL\]) with body surface area (BSA) (in meter square \[m\^2\]). LVESVI is presented in milliliter per meter square (mL/m\^2).
Left Ventricular End Diastolic Volume Index (LVEDVI) Baseline, Months 6 and 15 LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m\^2). LVEDVI was presented in mL/m\^2.
Fractional Myocardial Shortening (FS) Baseline, Months 6 and 15 FS was calculated as: (\[LVEDD - LVESD\] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters \[cm\]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV.
Left Ventricular Ejection Fraction (LVEF) Baseline, Months 6 and 15 LVEF was calculated as (\[LVEDV - LVESV\], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV.
Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL Week 26 up to Week 64