Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
cyclosporine & cellcept CSA, Gengraf, Neoral, Sandimmune, MMF, Mycophenolate Mofetil
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
prograf & cellcept FK, Tacrolimus, MMF, Mycophenolate Mofetil
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
(Active Comparator)
The substudy is for patients who need to be on steroids long term
cyclosporine, cellcept, & prednisone CSA, Neoral, Gengraf, Sandimmune, MMF, Mycophenolate Mofetil
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
prograf, cellcept, & prednisone FK, Tacrolimus, CSA, Gengraf, Neoral, Sandimmune, Cellcept
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
(Experimental)
low dose cni (cyclosporine or fk) and cellcept Gengraf, Neoral, Sandimmune, Tacrolimus, Prograf, MMF
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
rapamune and cellcept Sirolimus, MMF, Mycophenolate Mofetil
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
(Experimental)
The substudy is for patients who need to be on steroids long term
low dose cni (csa or fk), rapamune, & prednisone Gengraf, Neoral, Prograf, Tacrolimus, Sirolimus
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.
rapamune, cellcept, & prednisone Sirolimus, MMF, Mycophenolate Mofetil, Steroid
Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

Primary Outcomes

Measure
The minimization of negative side effects from steroids and Calcineurin Inhibitors.
time frame: Information assessed every 3 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.