Text Size

Calcineurin Inhibitor Sparing After Kidney Transplantation (CNI-Sparing)

This study is currently recruiting participants.
Verified March 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
Roche Pharma AG
Wyeth is now a wholly owned subsidiary of Pfizer
Genzyme
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01062555
First received: February 3, 2010
Last updated: March 13, 2013
Last verified: March 2013
History of Changes

February 3, 2010
March 13, 2013
October 2006
June 2020   (final data collection date for primary outcome measure)
The minimization of negative side effects from steroids and Calcineurin Inhibitors. [ Time Frame: Information assessed every 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062555 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Calcineurin Inhibitor Sparing After Kidney Transplantation
Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
CNI Side Effects
  • 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
  • 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
  • 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
  • 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
  • Active Comparator: Phase I
    Interventions:
    • Drug: Cyclosporine & Cellcept
    • Drug: Prograf & Cellcept
  • Active Comparator: Phase I Substudy
    The substudy is for patients who need to be on steroids long term
    Interventions:
    • Drug: Cyclosporine, Cellcept, & Prednisone
    • Drug: Prograf, Cellcept, & Prednisone
  • Experimental: Phase II
    Interventions:
    • Drug: Low Dose CNI (Cyclosporine or FK) and Cellcept
    • Drug: Rapamune and Cellcept
  • Experimental: Phase II Substudy
    The substudy is for patients who need to be on steroids long term
    Interventions:
    • Drug: Low dose CNI (CSA or FK), Rapamune, & Prednisone
    • Drug: Rapamune, Cellcept, & Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2020
June 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Scott M Rajala, BS 612-626-2989 srajala@umn.edu
Contact: Debra A Coffey 612-625-5665 dacoffey@umn.edu
United States
 
NCT01062555
0604M85327
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • Roche Pharma AG
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Genzyme
Principal Investigator: Arthur Matas, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP