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Calcineurin Inhibitor Sparing After Kidney Transplantation (CNI-Sparing)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Roche Pharma AG
Wyeth is now a wholly owned subsidiary of Pfizer
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01062555
First received: February 3, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
CNI Side Effects
Drug: Cyclosporine & Cellcept
Drug: Prograf & Cellcept
Drug: Cyclosporine, Cellcept, & Prednisone
Drug: Prograf, Cellcept, & Prednisone
Drug: Low Dose CNI (Cyclosporine or FK) and Cellcept
Drug: Rapamune and Cellcept
Drug: Low dose CNI (CSA or FK), Rapamune, & Prednisone
Drug: Rapamune, Cellcept, & Prednisone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • The minimization of negative side effects from steroids and Calcineurin Inhibitors. [ Time Frame: Information assessed every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2006
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phase I Drug: Cyclosporine & 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.
Other Name: CSA, Gengraf, Neoral, Sandimmune, MMF, Mycophenolate Mofetil
Drug: Prograf & 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.
Other Name: FK, Tacrolimus, MMF, Mycophenolate Mofetil
Active Comparator: Phase I Substudy
The substudy is for patients who need to be on steroids long term
Drug: Cyclosporine, Cellcept, & Prednisone
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.
Other Name: CSA, Neoral, Gengraf, Sandimmune, MMF, Mycophenolate Mofetil
Drug: Prograf, Cellcept, & Prednisone
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.
Other Name: FK, Tacrolimus, CSA, Gengraf, Neoral, Sandimmune, Cellcept
Experimental: Phase II Drug: Low Dose CNI (Cyclosporine or FK) and 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.
Other Name: Gengraf, Neoral, Sandimmune, Tacrolimus, Prograf, MMF
Drug: Rapamune and 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.
Other Name: Sirolimus, MMF, Mycophenolate Mofetil
Experimental: Phase II Substudy
The substudy is for patients who need to be on steroids long term
Drug: Low dose CNI (CSA or FK), Rapamune, & Prednisone
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.
Other Name: Gengraf, Neoral, Prograf, Tacrolimus, Sirolimus
Drug: Rapamune, Cellcept, & Prednisone
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.
Other Name: Sirolimus, MMF, Mycophenolate Mofetil, Steroid

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062555

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Roche Pharma AG
Wyeth is now a wholly owned subsidiary of Pfizer
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Arthur Matas, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01062555     History of Changes
Other Study ID Numbers: 0604M85327
Study First Received: February 3, 2010
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Sirolimus
Tacrolimus
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014