Calcineurin Inhibitor Sparing After Kidney Transplantation

• Status: Completed
• Trial end date: 2014-04-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Genzyme, a Sanofi Company; Roche Pharma AG; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus; Tacrolimus

Criteria

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