Calcineurin Inhibitor Sparing After Kidney Transplantation
This trial is active, not recruiting.
|Condition||cni side effects|
|Treatments||cyclosporine & cellcept, prograf & cellcept, cyclosporine, cellcept, & prednisone, prograf, cellcept, & prednisone, low dose cni (cyclosporine or fk) and cellcept, rapamune and cellcept, low dose cni (csa or fk), rapamune, & prednisone, rapamune, cellcept, & prednisone|
|Phase||phase 1/phase 2|
|Sponsor||University of Minnesota - Clinical and Translational Science Institute|
|Collaborator||Roche Pharma AG|
|Start date||October 2006|
|End date||May 2016|
|Trial size||600 participants|
|Trial identifier||NCT01062555, 0604M85327|
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.
|Intervention model||single group assignment|
The minimization of negative side effects from steroids and Calcineurin Inhibitors.
time frame: Information assessed every 3 months
Male or female participants at least 18 years old.
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
|Official title||Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation|
|Principal investigator||Arthur Matas, MD|
|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.|
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