NCT00141804

Brief Summary

To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2002

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

December 1, 2005

Status Verified

August 1, 2005

First QC Date

August 31, 2005

Last Update Submit

November 30, 2005

Conditions

Kidney Transplantation

Keywords

renal transplantationimmunosuppressionprevention of acute rejection

Outcome Measures

Primary Outcomes (3)

  • - time to first biopsy proven acute rejection episode at month 12

  • - graft failure at month 12

  • - discontinuation of study medication at month 12

Secondary Outcomes (5)

  • - patient and graft survival at month 12

  • - incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12

  • - Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)

  • - incidence and severity of infections at month 12

  • - incidence of adverse events at month 12

Interventions

SirolimusDRUG

Eligibility Criteria

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

You may qualify if:

  • first kidney transplantation
  • re-transplantation
  • non-related living donor transplantation
  • patients \> 18 years
  • patients have given their written consent after being informed
  • female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test

You may not qualify if:

  • related living donation
  • patients with known HIV-anamnesis
  • patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
  • patients with present malignant disease
  • patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
  • patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority
  • other reasons which depend on the assessment of the physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Heiner H. Wolters, Dr. med.

    University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

January 1, 2002

Study Completion

June 1, 2005

Last Updated

December 1, 2005

Record last verified: 2005-08

Locations

DE(1)