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A Study of NeoRecormon in Patients With Chronic Kidney Disease.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437723
First Posted: February 21, 2007
Last Update Posted: May 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hoffmann-La Roche
  Purpose
This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hb level, decline in renal function, 24h proteinuria, creatinine clearance. [ Time Frame: Throughout study ]

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

Enrollment: 90
Study Completion Date: April 2008
Arms Assigned Interventions
Experimental: 1 Drug: epoetin beta [NeoRecormon]
At a dose to achieve and maintain an Hb level of 120-135g/dL.
No Intervention: 2

  Eligibility

Information from the National Library of Medicine

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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, not on dialysis;
  • Hb <110g/L.

Exclusion Criteria:

  • unstable hypertension;
  • acute infections;
  • use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
  • myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
  Contacts and Locations
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): NCT00437723


Locations
Serbia
Belgrade, Serbia, 11000
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00437723     History of Changes
Other Study ID Numbers: ML20200
First Submitted: February 19, 2007
First Posted: February 21, 2007
Last Update Posted: May 14, 2009
Last Verified: May 2009

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