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Calcineurin Inhibitor Sparing After Kidney Transplantation (CNI-Sparing)

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ClinicalTrials.gov Identifier: NCT01062555
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : February 13, 2018
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

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.

Condition or disease Intervention/treatment 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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation
Study Start Date : October 2006
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The minimization of negative side effects from steroids and Calcineurin Inhibitors. [ Time Frame: Information assessed every 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01062555     History of Changes
Other Study ID Numbers: 0604M85327
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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