Phase 2
N=527
Calcineurin Inhibitor Sparing After Kidney Transplantation
CNI Side Effects
Bottom Line
View on ClinicalTrials.gov: NCT01062555 ↗Enrolled (actual)
527
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Phase I: The Minimization of Negative Side Effects - Patient Survival — 99; 98 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclosporine & Cellcept (Drug); Prograf & Cellcept (Drug); Low Dose CNI (Cyclosporine or FK) and Cellcept (Drug); Rapamune and Cellcept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: The Minimization of Negative Side Effects - Patient Survival |
99; 98 | — |
| PRIMARY Phase II: The Minimization of Negative Side Effects - Patient Survival |
89; 85 | — |
| PRIMARY Phase I: The Minimization of Negative Side Effects - Graft Survival |
99; 99 | — |
| PRIMARY Phase II: The Minimization of Negative Side Effects - Graft Survival |
80; 78 | — |
| PRIMARY Phase I: Acute Rejection-Free Survival |
80; 85 | — |
| PRIMARY Phase II: Acute Rejection-Free Survival |
76; 81 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Kidney Transplant Recipients > 18 years old
- First or Second Kidney Transplant only
Exclusion Criteria
- Kidney Transplant Recipients 2 kidney transplants
- Kidney Transplant Recipients with an already functioning non-renal transplant
- Kidney Transplant Recipients who receive another organ simultaneously at the same time of their kidney transplant (example: Kidney/pancreas, kidney/liver)
- Non-skin malignancy with 2 years previous to enrollment
- Donor Specific Antibodies to kidney donor
Data sourced from ClinicalTrials.gov (NCT01062555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.