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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00413101
First received: December 18, 2006
Last updated: May 13, 2009
Last verified: May 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: 1 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
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00413101     History of Changes
Other Study ID Numbers: ML20201
Study First Received: December 18, 2006
Last Updated: May 13, 2009
Health Authority: Serbia: Ministry of Health

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 16, 2014