drugset / Trial / NCT01053221
Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.