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Influence of Sirolimus and MMF on Vascular Function and Markers of Cellular Function in Renal Transplant Recipients

NCT00204321 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-01-13

No results posted yet for this study

Summary

Chronic transplant nephropathy and cardiovascular death are the main reasons for loss of transplanted organs after kidney transplantation.

Vascular changes, induced by hypertension and/or immunological processes, determine long time transplant survival.

It will be tested whether the withdrawal of calcineurininhibitors will improve the vessel wall function in renal transplant patients. It is supposed that this immunosuppressive regimen reduces the activation of endothelial cells with important impact on arteriosclerosis and therefore on patient and transplant survival.

Conditions

  • Renal Transplantation

Interventions

DRUG

sirolimus (drug), mmf (drug)

Sponsors & Collaborators

  • Else Kröner Fresenius Foundation

    collaborator OTHER

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Martin Hausberg, MD · UKM - Medical Department D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-01-31
Completion
2010-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00204321 on ClinicalTrials.gov