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
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01306409     History of Changes
Other Study ID Numbers: 362/09
Study First Received: February 15, 2011
Last Updated: October 18, 2011
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014