CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Arm 1 Everolimus/Reduced dose tacrolimusdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01935128
NCT01935128Phase 4Completed
CompareCT.gov

A 24-month, Single Center, Pilot, Open Label, Controlled Trial to Evaluate the Efficacy and Safety of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Reduced Dose Tacrolimus/Everolimus in Adult Renal Transplant Recipients Following Campath® Induction and Steroid Avoidance

University of Toledo Health Science Campus·interventional·Posted Sep 4, 2013·Updated May 26, 2022

In Brief

A Phase 4 clinical trial evaluating Arm 1 Everolimus/Reduced dose tacrolimus for Renal Transplant. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate whether conversion to everolimus (Zortress®), allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity (measured by increased creatinine clearance) and lengthen overall graft (kidney transplant) survival (measured by 2-3 year graft survival).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplant
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 4, 2013
Enrollment StartJul 3, 2013
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 12.8 years ago

Interventions

Arm 1 Everolimus/Reduced dose tacrolimusdrug

Immunosuppression drug intervention