NCT00248313

Brief Summary

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
470

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_3

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

July 1, 2000

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 10, 2010

Status Verified

November 1, 2007

First QC Date

November 2, 2005

Last Update Submit

March 9, 2010

Conditions

Kidney Disease

Keywords

Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Kidney Function at 12 months after transplantation.

Secondary Outcomes (1)

  • Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.

Interventions

Rapamune®DRUG

Eligibility Criteria

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

You may qualify if:

  • Age: = to ≥ 18 years.
  • End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor.
  • Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).

You may not qualify if:

  • Evidence of active systemic or localised major infection prior to initial Rapamune® administration.
  • Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening.
  • Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Diseases

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 3, 2005

Study Start

July 1, 2000

Study Completion

October 1, 2007

Last Updated

March 10, 2010

Record last verified: 2007-11