Calcineurin Inhibitor Sparing After Kidney Transplantation (CNI-Sparing)

University of Minnesota (UMN)

Status and phase: Completed; Phase 2; Phase 1

Conditions: CNI Side Effects

Treatments: Drug: Low Dose CNI (Cyclosporine or FK) and Cellcept; Drug: Rapamune and Cellcept; Drug: Cyclosporine & Cellcept; Drug: Prograf & Cellcept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01062555

0604M85327

Details and patient eligibility

About

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.

Full description

It is clear that minimizing the use of CNIs may be beneficial to some or all kidney transplant recipients. The purpose of this study is to determine whether minimization of these CNI drugs will improve patient survival rates and long-term kidney function.

If the subject agrees to participate in this research project, they will be randomly assigned to one of two different immunosuppression drug combinations. All of the drugs used in this study are standard FDA Approved immunosuppressive drugs currently in use by transplant patients. It is unclear however, which combination provides a better long-term outcome.

If after six months of being on the study the subject has not experienced a rejection episode that excludes them from participating in the second phase of this study, they will asked whether or not they would like to continue the study. If they decide to participate in Phase II, there will be another randomization to one of two different immunosuppression drug combinations. This will involve either being assigned to a group that will have their CNI dose lowered or a group that will have their CNI drug stopped and replaced with a non-CNI drug called Sirolimus. Phase II begins at 6 months post-transplant and a second consent will be obtained for those who participate in Phase II.

Enrollment: 527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney Transplant Recipients > 18 years old
• First or Second Kidney Transplant only

Exclusion criteria

• Kidney Transplant Recipients < 18 years old
• Kidney Transplant Recipients who have a history of > 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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527 participants in 4 patient groups

Phase I Arm 1

Active Comparator group

Description:

CSA and MMF

Treatment:

Drug: Cyclosporine & Cellcept

Phase I Arm 2

Active Comparator group

Description:

FK and MMF

Treatment:

Drug: Prograf & Cellcept

Phase II Arm 1

Active Comparator group

Description:

Low CNI and MMF

Treatment:

Drug: Low Dose CNI (Cyclosporine or FK) and Cellcept

Phase II Arm 2

Active Comparator group

Description:

Rapa and MMF

Treatment:

Drug: Rapamune and Cellcept