NCT00204321

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

Enrollment Period

2.6 years

First QC Date

September 12, 2005

Last Update Submit

January 12, 2010

Conditions

Renal Transplantation

Keywords

rejectionvesselwall functionendothelial cell functionmonocytes

Outcome Measures

Primary Outcomes (3)

  • distensibility

  • sympathetic nervous system activity

  • endothelial cell marker expression

Secondary Outcomes (1)

  • monocyte survival

Interventions

sirolimus (drug), mmf (drug)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • renal transplantation stable function

You may not qualify if:

  • acute rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKM

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Rejection, Psychology

Interventions

SirolimusPharmaceutical PreparationsMycophenolic Acid

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Martin Hausberg, MD

    UKM - Medical Department D

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2010

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

DE(1)