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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354341
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Epoetin beta Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (Early 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.
Drug: Epoetin beta
Other Name: NeoRecormon

Active Comparator: Group 2 (No/Late 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.
Drug: Epoetin beta
Other Name: NeoRecormon




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354341


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Principal Investigator: Ebenhard Ritz, Prof. Dr. unaffliated
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00354341    
Other Study ID Numbers: MA16620
First Posted: July 20, 2006    Key Record Dates
Results First Posted: March 31, 2016
Last Update Posted: March 31, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Diabetic Nephropathies
Anemia
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Epoetin Alfa
Hematinics