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

Hoffmann-La Roche170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Anemia

Interventions

Epoetin betaDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (63)

Outcomes

Primary Outcomes

Change From Baseline in Left Ventricle Mass Index (LVMI) at 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).

Time frame: Baseline, Month 15

Secondary Outcomes

Left Ventricular End Systolic Volume Index (LVESVI)

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).

Time frame: Baseline, Months 6 and 15

Left Ventricular End Diastolic Volume Index (LVEDVI)

LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m\^2). LVEDVI was presented in mL/m\^2.

Time frame: Baseline, Months 6 and 15

Fractional Myocardial Shortening (FS)

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.

Time frame: Baseline, Months 6 and 15

Left Ventricular Ejection Fraction (LVEF)

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.

Data from ClinicalTrials.gov

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Linz, Austria

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São Paulo, Brazil

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Jihlava, Czechia

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Liberec, Czechia

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Copenhagen, Denmark

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Roskilde, Denmark

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Jyväskylä, Finland

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Heidelberg, Germany

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München, Germany

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Alexandroupoli, Greece

...and 53 more locations