Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01306409
First received: February 15, 2011
Last updated: October 18, 2011
Last verified: October 2011

February 15, 2011
October 18, 2011
January 2011
July 2011   (final data collection date for primary outcome measure)
Reticulocyte count on day 7 [ Time Frame: day 7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01306409 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents

The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Renal Anemia
  • Drug: cera, darbepoetin, epoetin-beta
    Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
  • Drug: ESA
    Sequential application of three different ESA
Experimental: A
Sequential application of different ESA
Interventions:
  • Drug: cera, darbepoetin, epoetin-beta
  • Drug: ESA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • signed informed consent
  • age > 18 years, dialysis dependent chronic renal failure
  • hemodialysis three times a week
  • Kt/V > 1,2 od URR > 65%
  • hemoglobin between 11 and 13 g/dl within the last 2 months
  • hemoglobin change +/- 1g/dl within the last 4 weeks
  • ESA for at least 8 weeks
  • Ferritin > 300 ng/ml and Tsat > 25%

Exclusion Criteria:

  • Significant bleeding in the last 8 weeks
  • blood transfusion within the last 8 weeks
  • hemoglobin disorder
  • hemolysis
  • Malignant disease
  • Significant inflammation
  • Acute infection
  • CRP > 30 mg/l
  • Temporary vascular dialysis access
  • Vitamin B12 deficiency
  • Folic acid deficiency
  • Not controlled hyperparathyroidism
  • Not controlled hypertension
  • Epilepsia within thze last 6 months
  • Thrombocyte count > 500 x 10^9 /l
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01306409
362/09
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Roche Pharma AG
Principal Investigator: Michael Dickenmann, MD Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
University Hospital, Basel, Switzerland
October 2011

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