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

March 1, 2016 updated by: Hoffmann-La Roche

An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
  • Brazil
      • Sao Paulo, Brazil, 04038-002
  • Czech Republic
      • Jihlava, Czech Republic, 586 33
      • Liberec, Czech Republic, 460 63
  • Denmark
      • Koebenhavn, Denmark, 2100
      • Roskilde, Denmark, 4000
  • Finland
      • Jyvaeskylae, Finland, 40620
  • Germany
      • Heidelberg, Germany, 69115
      • Muenchen, Germany, 81675
  • Greece
      • Alexandroupolis, Greece, 68100
      • Athens, Greece, 11526
      • Ioannina, Greece, 45500
      • Nikea, Greece, 18354
      • Thessaloniki, Greece, 54629
      • Thessaloniki, Greece, 546 36
      • Veria, Greece, 59100
  • Hungary
      • Budapest, Hungary, 1115
      • Budapest, Hungary, 1076
      • Miskolc, Hungary, 3526
      • Pecs, Hungary, 7624
      • Szombathely, Hungary, 9700
  • Italy
      • Ancona, Italy, 60121
      • Cagliari, Italy, 09100
      • Caserta, Italy, 81100
      • Cinisello Balsamo, Italy, 20092
      • Desio, Italy, 20033
      • Lecco, Italy, 23900
      • Messina, Italy, 98122
      • Milano, Italy, 20162
      • Milano, Italy, 20132
  • Mexico
      • Chihuahua, Mexico, 31238
      • Mexico City, Mexico, 14000
      • Monterrey, Mexico, 64460
  • Poland
      • Bialystok, Poland, 15-540
      • Katowice, Poland, 40-027
      • Radom, Poland, 26 600
  • Russian Federation
      • Moscow, Russian Federation, 117036
      • Moscow, Russian Federation, 109263
      • Moscow, Russian Federation, 125315
      • Moscow, Russian Federation, 123 448
  • Singapore
      • Singapore, Singapore, 169608
  • Spain
      • Baracaldo, Spain, 48903
      • Barcelona, Spain, 08907
      • Galdakao, Spain, 48960
      • La Coruna, Spain, 15006
      • Madrid, Spain, 28046
      • Madrid, Spain, 28007
      • Valencia, Spain, 46017
  • Sweden
      • Stockholm, Sweden, 118 83
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
      • Bangkok, Thailand, 10220
      • Chiang Mai, Thailand, 50200
      • Chonburi, Thailand, 20000
  • United Kingdom
      • Belfast, United Kingdom, BT9 7LJ
      • Cambridge, United Kingdom, CB2 2QQ
      • London, United Kingdom, SE22 8PT
      • London, United Kingdom, N18 1QX
      • London, United Kingdom, E1 1BB
      • Middlesborough, United Kingdom, TS4 3BW
      • Salford, United Kingdom, M6 8HD
      • Sheffield, United Kingdom, S57AU
      • Wrexham, United Kingdom, LL13 7TD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • NeoRecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Month 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Months 6 and 15
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.
Baseline, Months 6 and 15
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.
Baseline, Months 6 and 15
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.
Baseline, Months 6 and 15
Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL
Time Frame: Week 26 up to Week 64
Week 26 up to Week 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Principal Investigator: Ebenhard Ritz, Prof. Dr., Unaffliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA16620

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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