drugset / Trial / NCT01053221

Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation

NCT01053221

Phase 2 Terminated 16 enrolled University of Wisconsin, Madison
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal allograft function in the absence of long-term calcineurin inhibitors in this fully matched renal transplant cohort.

Timeline

Start
2006-03
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide
Comparator Mycophenolate Mofetil Small molecule 750 mg Oral
Comparator Mycophenolate Sodium Unknown 540 mg Oral
Comparator Tacrolimus Small molecule

Indications

No indication recorded.