CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 527 enrolled
Drug / intervention
Cyclosporine & Cellcept +3 moredrug
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/NCT01062555
NCT01062555Phase 2Completed
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Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation

University of Minnesota·interventional·Posted Feb 4, 2010·Updated Dec 14, 2020

In Brief

A Phase 2 clinical trial evaluating Cyclosporine & Cellcept, Prograf & Cellcept, and 2 other interventions for CNI Side Effects. Completed, enrolled 527 participants across 1 site.

Detailed Summary

Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. In some patients, this toxicity is thought to be associated with loss of transplant function in those who have had their transplants for many years. The introduction of new immunosuppression medications however, has provided the opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the kidney.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCNI Side Effects
CountriesUnited States
CollaboratorsRoche Pharma AG, Wyeth is now a wholly owned subsidiary of Pfizer, Genzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 4, 2010
Enrollment StartOct 1, 2006
Primary CompletionApr 3, 2014
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 16.4 years ago

Interventions

Cyclosporine & Cellceptdrug

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

Prograf & Cellceptdrug

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

Low Dose CNI (Cyclosporine or FK) and Cellceptdrug

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

Rapamune and Cellceptdrug

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.