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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306409
First Posted: March 1, 2011
Last Update Posted: October 19, 2011
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.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
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 Intervention Phase
Renal Anemia Drug: cera, darbepoetin, epoetin-beta Drug: ESA Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

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

Enrollment: 9
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT01306409


Locations
Switzerland
Nephrology and Transplantaton Immunology
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Roche Pharma AG
Investigators
Principal Investigator: Michael Dickenmann, MD Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
  More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01306409     History of Changes
Other Study ID Numbers: 362/09
First Submitted: February 15, 2011
First Posted: March 1, 2011
Last Update Posted: October 19, 2011
Last Verified: October 2011

Keywords provided by University Hospital, Basel, Switzerland:
anemia
kidney disease

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Darbepoetin alfa
Hematinics