Clinical trial NCT00354341: (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15
timeFrame: Baseline, Month 15
Secondary outcomes:
measure: Left Ventricular End Systolic Volume Index (LVESVI)
timeFrame: Baseline, Months 6 and 15
measure: Left Ventricular End Diastolic Volume Index (LVEDVI)
timeFrame: Baseline, Months 6 and 15
measure: Fractional Myocardial Shortening (FS)
timeFrame: Baseline, Months 6 and 15
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline, Months 6 and 15
measure: Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL
timeFrame: Week 26 up to Week 64
Other outcomes:
Locations:
city: Linz
country: Austria
city: Sao Paulo
country: Brazil
city: Jihlava
country: Czech Republic
city: Liberec
country: Czech Republic
city: Koebenhavn
country: Denmark
city: Roskilde
country: Denmark
city: Jyvaeskylae
country: Finland
city: Heidelberg
country: Germany
city: Muenchen
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Nikea
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Veria
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Szombathely
country: Hungary
city: Ancona
country: Italy
city: Cagliari
country: Italy
city: Caserta
country: Italy
city: Cinisello Balsamo
country: Italy
city: Desio
country: Italy
city: Lecco
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Chihuahua
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Bialystok
country: Poland
city: Katowice
country: Poland
city: Radom
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Singapore
country: Singapore
city: Baracaldo
country: Spain
city: Barcelona
country: Spain
city: Galdakao
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Stockholm
country: Sweden
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Chonburi
country: Thailand
city: Belfast
country: United Kingdom
city: Cambridge
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Salford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Wrexham
country: United Kingdom
Study officials:
affiliation: unaffliated
name: Ebenhard Ritz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.