Clinical trial NCT00321919: A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia
Official title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 605
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 evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* not receiving renal replacement therapy.

Exclusion Criteria:

* women who are pregnant or lactating;
* previous treatment with erythropoietin or other erythropoietic substance;
* blood transfusion within the last 3 months;
* need for dialysis expected in the next 6 months;
* administration of another investigational drug within 30 days preceding study start, or during the study.

Primary outcomes:
measure: Median Time to First Cardiovascular Event
timeFrame: Up to 4 years
Secondary outcomes:
measure: Median Time to Death Due to Cardiovascular Events
timeFrame: Up to 4 years
measure: Number of Participants Who Died Due to Cardiovascular Events
timeFrame: Up to 4 years
measure: Median Time to Death Due to All Causes
timeFrame: Up to 4 years
measure: Number of Participants Who Died Due to All Causes
timeFrame: Up to 4 years
measure: Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)
timeFrame: Up to 4 years
measure: Median Time to First Cardiovascular Intervention
timeFrame: Up to 4 years
measure: Total Number of Cardiovascular Intervention
timeFrame: Up to 4 years
measure: Median Time to First Hospitalization Due to Cardiovascular Events
timeFrame: Up to 4 years
measure: Duration of Hospitalization for Cardiovascular Events
timeFrame: Up to 4 years
measure: Mean Change From Baseline in Left Ventricular Mass Index (LVMI)
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
measure: Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
measure: Mean Change From Baseline in Left Ventricular Volume (LV Volume )
timeFrame: Baseline, Week 12, Week 24, Week 36, and Week 48
measure: Mean Values of Echocardiography Parameters
timeFrame: Baseline, Year 1, Year 2, Year 3, and Year 4
measure: Mean Values of Body Surface Area
timeFrame: Baseline, Year 1, Year 2, Year 3, and Year 4.
measure: Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire
timeFrame: Baseline, Year 1, and Year 2
measure: Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs
timeFrame: Up to 4 years
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Baseline, every 3 months up to 4 years
Other outcomes:
Locations:
city: Linz
country: Austria
city: St Pölten
country: Austria
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Brno
country: Czech Republic
city: Havirov
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Fredericia
country: Denmark
city: Herlev
country: Denmark
city: Holbaek
country: Denmark
city: Roskilde
country: Denmark
city: Jyväskylä
country: Finland
city: Tampere
country: Finland
city: Amiens
country: France
city: Angouleme
country: France
city: Bordeaux
country: France
city: Boulogne
country: France
city: Colmar
country: France
city: Lyon
country: France
city: Montpellier
country: France
city: Paris
country: France
city: Saint Brieuc
country: France
city: Troyes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Berlin
country: Germany
city: Villingen-schwenningen
country: Germany
city: Würzburg
country: Germany
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Veria
country: Greece
city: Hong Kong
country: Hong Kong
city: Dublin
country: Ireland
city: Bologna
country: Italy
city: Busto Arsizio
country: Italy
city: Cagliari
country: Italy
city: Cinisello Balsamo
country: Italy
city: Lecco
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Parma
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Trieste
country: Italy
city: Vimercate
country: Italy
city: Cuernavaca
country: Mexico
city: Tijuana
country: Mexico
city: Oslo
country: Norway
city: Gdansk
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Wroclaw
country: Poland
city: Almada
country: Portugal
city: Carnaxide
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Barcelona
country: Spain
city: Las Palmas de Gran Canaria
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Boras
country: Sweden
city: Helsingborg
country: Sweden
city: Jonkoping
country: Sweden
city: Karlstad
country: Sweden
city: Norrkoping
country: Sweden
city: Oerebro
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Belfast
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Salford
country: United Kingdom
city: Southampton
country: United Kingdom
city: Surrey
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Locatelli F, Eckardt KU, Macdougall IC, Tsakiris D, Clyne N, Burger HU, Scherhag A, Drueke TB; Cardiovascular Risk Reduction in Early Anaemia Trial with Epoetin Beta investigators and coordinators. Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study. Curr Med Res Opin. 2010 Nov;26(11):2543-52. doi: 10.1185/03007995.2010.516237. Epub 2010 Sep 17.
citation: Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. doi: 10.1056/NEJMoa062276.