A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00413101

Purpose

This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L.

Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

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

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Hb level, BP. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
LVMI ejection fraction, ejection fraction. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	50
Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Experimental	Drug: epoetin beta [NeoRecormon] At a dose to achieve and maintain an Hb level of 120-135g/L

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-75 years of age;
end-stage renal disease;
on renal dialysis >= 3 months;
receiving NeoRecormon treatment >= 3 months;
Hb stable and <105g/L, and LVMI >160g/m2.

Exclusion Criteria:

unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
use of any ESA other than NeoRecormon;
acute infection;
use of iv NeoRecormon.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413101

Locations

Serbia

NOVI SAD, Serbia, 21000

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20201
Study First Received:	December 18, 2006
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00413101 History of Changes
Health Authority:	Serbia: Ministry of Health

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Hematologic Diseases

Benzocaine
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Hematologic Diseases

Kidney Failure, Chronic
Anemia
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009