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Completed

NCT Number: NCT00354341

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epoetin beta

Drug

Other names: NeoRecormon

Primary outcomes

  1. Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15

    Time frame: 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 outcomes

  1. Left Ventricular End Systolic Volume Index (LVESVI)

    Time frame: 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).

  2. Left Ventricular End Diastolic Volume Index (LVEDVI)

    Time frame: 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.

  3. Fractional Myocardial Shortening (FS)

    Time frame: 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.

  4. Left Ventricular Ejection Fraction (LVEF)

    Time frame: 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.

  5. Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL

    Time frame: Week 26 up to Week 64

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jul 20, 2006
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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