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

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. Identifier: NCT01306409
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : October 19, 2011
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment Phase
Renal Anemia Drug: cera, darbepoetin, epoetin-beta Drug: ESA Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents
Study Start Date : January 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: A
Sequential application of different ESA
Drug: cera, darbepoetin, epoetin-beta
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk

Drug: ESA
Sequential application of three different ESA

Primary Outcome Measures :
  1. Reticulocyte count on day 7 [ Time Frame: day 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01306409

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Nephrology and Transplantaton Immunology
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Roche Pharma AG
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Principal Investigator: Michael Dickenmann, MD Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01306409    
Other Study ID Numbers: 362/09
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: October 19, 2011
Last Verified: October 2011
Keywords provided by University Hospital, Basel, Switzerland:
kidney disease
Additional relevant MeSH terms:
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Hematologic Diseases
Darbepoetin alfa