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Effects of Anemia Correction on Vascular and Monocyte Function in Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00204334
First received: September 12, 2005
Last updated: January 12, 2010
Last verified: May 2008
History of Changes
  Purpose

Correction of anaemia in renal transplant recipients by parenteral application of recombinant erythropoietin and if necessary iron will improve large artery function (endothelial function and elasticity), as assessed by ultrasound techniques and applanation tonometry.

The changes in large artery function will be reflected by changes in serological markers of endothelial function and oxidative stress and by changes in monocyte function and apoptosis.

There are gender differences in the responses of vascular function to correction of anemia.

Besides improvement of large artery function, correction of anemia will also affect parameters of graft function, i.e. glomerular and tubular proteinuria.


Condition Intervention Phase
Kidney Transplantation
Anemia
 Drug: darbopoeitin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Anemia Correction on Vascular Function, Endothelial Cell Markers and Monocyte Apoptosis in Renal Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Vessel wall stiffness

Secondary Outcome Measures:
  • expression of endothelial cell markers

Estimated Enrollment: 60
Study Start Date: June 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

kidney transplant recipient stable kidney function Hb between 10mg/ml and 10.5mg/ml

Exclusion Criteria:

acute rejection Hb above 12.0mg/dl

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204334

Locations
Germany
UKM
Münster, NRW, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Amgen
Investigators
Principal Investigator: Martin Hausberg, MD UKM- Medical Department D
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00204334     History of Changes
Other Study ID Numbers: Haus_Lang-Endothel-Mono-Hb, DE-2004-4077
Study First Received: September 12, 2005
Last Updated: January 12, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
Kidney transplantation
anemia
vascular endothelium
monocytes
apoptosis

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013