CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Rapamycindrug
Likely dose
Rapamycin initial dose 10 mg daily for 3 days, then adjusted to target whole blood trough 5-15 ng/mLAI-extracted
Key inclusion· 6
  • ✓Recipient of cadaveric or living donor renal transplant
  • ✓Age >12 years at time of transplant
  • ✓At least 3 months post-transplant
  • ✓Currently on calcineurin inhibitor-based immunosuppression since transplant
Key exclusion· 11
  • ✕Recipient of solid organ transplant other than kidney
  • ✕Currently dialysis dependent
  • ✕Recurrence of primary renal disease or de novo renal disease
  • ✕Estimated creatinine clearance <25 ml/min by Cockcroft/Gault formula

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00223678
NCT00223678Phase 4Completed
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Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

Vanderbilt University Medical Center·interventional·Posted Sep 22, 2005·Updated Jun 21, 2017

In Brief

A Phase 4 clinical trial evaluating Rapamycin for Kidney Transplant. Completed, enrolled 20 participants across 1 site.

Detailed Summary

A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJun 1, 2000
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 20.8 years ago

Interventions

Rapamycindrug

Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15