Clinical trial NCT01062555: Calcineurin Inhibitor Sparing After Kidney Transplantation
Official title: Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: CNI Side Effects
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Wyeth is now a wholly owned subsidiary of Pfizer
name: Genzyme, a Sanofi Company
First posted: 2010-02-04
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Phase I: The Minimization of Negative Side Effects - Patient Survival
timeFrame: 6 months
measure: Phase II: The Minimization of Negative Side Effects - Patient Survival
timeFrame: up to 7 years
measure: Phase I: The Minimization of Negative Side Effects - Graft Survival
timeFrame: 6 months
measure: Phase II: The Minimization of Negative Side Effects - Graft Survival
timeFrame: up to 7 years
measure: Phase I: Acute Rejection-Free Survival
timeFrame: 6 months
measure: Phase II: Acute Rejection-Free Survival
timeFrame: up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Arthur Matas, MD
role: PRINCIPAL_INVESTIGATOR
References: