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

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ClinicalTrials.gov Identifier: NCT00413101
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : May 14, 2009
Sponsor:
Information provided by:
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Drug: epoetin beta [NeoRecormon] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Hb level, BP. [ Time Frame: Throughout study ]
  2. LVMI ejection fraction, ejection fraction. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. [ Time Frame: Throughout study ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413101


Locations
Serbia
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00413101     History of Changes
Other Study ID Numbers: ML20201
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

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