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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
February 19, 2007
February 21, 2007
May 14, 2009
Not Provided
Not Provided
Hb level, decline in renal function, 24h proteinuria, creatinine clearance. [ Time Frame: Throughout study ]
Hb level, decline in renal function, 24h proteinuria, creatinine clearance.
Complete list of historical versions of study NCT00437723 on ClinicalTrials.gov Archive Site
SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. [ Time Frame: Throughout study ]
SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
Not Provided
Not Provided
 
A Study of NeoRecormon in Patients With Chronic Kidney Disease.
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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anemia
Drug: epoetin beta [NeoRecormon]
At a dose to achieve and maintain an Hb level of 120-135g/dL.
  • Experimental: 1
    Intervention: Drug: epoetin beta [NeoRecormon]
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2008
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Serbia
Former Serbia and Montenegro
 
NCT00437723
ML20200
Not Provided
Not Provided
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP