A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00321919

First received: May 3, 2006

Last updated: October 17, 2006

Last verified: May 2006

History of Changes

Purpose

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.

Condition	Intervention	Phase
Anemia	Drug: epoetin beta [NeoRecormon]	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Efficacy: Combined endpoint of all major cardiovascular events

Secondary Outcome Measures:

Efficacy: All-cardiovascular and all-cause mortality, chronic heart failure, cardiovascular intervention, hospital admissions, cardiac structure and function by ECHO cardiography, QOL. Safety: BP/antihypertension medication, AEs, lab tests.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321919

Show 97 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Principal Investigator:

Tilman B Drueke, Prof.

unaffliated

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Locatelli F, Eckardt KU, Macdougall IC, Tsakiris D, Clyne N, Burger HU, Scherhag A, Drüeke 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. Epub 2010 Sep 17.

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.

ClinicalTrials.gov Identifier:	NCT00321919 History of Changes
Other Study ID Numbers:	BA16169
Study First Received:	May 3, 2006
Last Updated:	October 17, 2006
Health Authority:	Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:

Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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