NCT00507793

Brief Summary

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2000

Typical duration for phase_4

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

April 1, 2000

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
Last Updated

July 27, 2007

Status Verified

July 1, 2007

First QC Date

July 26, 2007

Last Update Submit

July 26, 2007

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.

Secondary Outcomes (1)

  • Safety evaluations will include physical exams, vital signs, CBC with differential, platelet count, blood chemistries, fasting lipid profiles, BUN or urea, serum creatinine, adverse event monitoring and calculated creatinine clearance.

Interventions

SirolimusDRUG
CyclosporineDRUG

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
  • Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

You may not qualify if:

  • Antibody induction within one week of current transplantation
  • Multiorgan transplants
  • Patients at high-risk of rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Muhlbacher F, Neumayer HH, del Castillo D, Stefoni S, Zygmunt AJ, Budde K; European Rapamune Cyclosporine Minimization Study Group. The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids: results from an open-label comparative study. Transpl Int. 2014 Feb;27(2):176-86. doi: 10.1111/tri.12228. Epub 2013 Nov 25.

    PMID: 24266855DERIVED

MeSH Terms

Interventions

SirolimusCyclosporine

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

April 1, 2000

Study Completion

June 1, 2002

Last Updated

July 27, 2007

Record last verified: 2007-07