Back to results(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epoetin beta
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1 (Early Epoetin Beta)
Group 2 (No/Late Epoetin Beta)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
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.
Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354341
Brief Title
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Early Epoetin Beta)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 (No/Late Epoetin Beta)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Epoetin beta
Other Intervention Name(s)
NeoRecormon
Primary Outcome Measure Information:
Title
Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15
Description
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 Outcome Measure Information:
Title
Left Ventricular End Systolic Volume Index (LVESVI)
Description
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
Title
Left Ventricular End Diastolic Volume Index (LVEDVI)
Description
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
Title
Fractional Myocardial Shortening (FS)
Description
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
Title
Left Ventricular Ejection Fraction (LVEF)
Description
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.
Time Frame
Baseline, Months 6 and 15
Title
Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL
Time Frame
Week 26 up to Week 64
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebenhard Ritz, Prof. Dr.
Organizational Affiliation
unaffliated
Official's Role
Principal Investigator
Facility Information:
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Sao Paulo
ZIP/Postal Code
04038-002
Country
Brazil
City
Jihlava
ZIP/Postal Code
586 33
Country
Czech Republic
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Koebenhavn
ZIP/Postal Code
2100
Country
Denmark
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
City
Jyvaeskylae
ZIP/Postal Code
40620
Country
Finland
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
City
Athens
ZIP/Postal Code
11526
Country
Greece
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
City
Nikea
ZIP/Postal Code
18354
Country
Greece
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54629
Country
Greece
City
Veria
ZIP/Postal Code
59100
Country
Greece
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Ancona
ZIP/Postal Code
60121
Country
Italy
City
Cagliari
ZIP/Postal Code
09100
Country
Italy
City
Caserta
ZIP/Postal Code
81100
Country
Italy
City
Cinisello Balsamo
ZIP/Postal Code
20092
Country
Italy
City
Desio
ZIP/Postal Code
20033
Country
Italy
City
Lecco
ZIP/Postal Code
23900
Country
Italy
City
Messina
ZIP/Postal Code
98122
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
City
Radom
ZIP/Postal Code
26 600
Country
Poland
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123 448
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125315
Country
Russian Federation
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
City
Bangkok
ZIP/Postal Code
10220
Country
Thailand
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Chonburi
ZIP/Postal Code
20000
Country
Thailand
City
Belfast
ZIP/Postal Code
BT9 7LJ
Country
United Kingdom
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
City
London
ZIP/Postal Code
SE22 8PT
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S57AU
Country
United Kingdom
City
Wrexham
ZIP/Postal Code
LL13 7TD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17261422
Citation
Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger U, de Alvaro F; Anemia Correction in Diabetes Study Investigators. Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study. Am J Kidney Dis. 2007 Feb;49(2):194-207. doi: 10.1053/j.ajkd.2006.11.032. Erratum In: Am J Kidney Dis. 2007 Apr;49(4):562.
Results Reference
derived
Learn more about this trial
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
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