Calcineurin Inhibitor Sparing After Kidney Transplantation

NCT01062555

Last updated date
Study Location
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
CNI Side Effects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Kidney Transplant Recipients > 18 years old

- First or Second Kidney Transplant only

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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CNI Side EffectsCalcineurin Inhibitor Sparing After Kidney Transplantation
NCT01062555
  1. Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Calcineurin Inhibitor Sparing After Kidney Transplantation
Official Title  ICMJE Calcineurin-Sparing in a Steroid-free Maintenance Immunosuppression Protocol After Kidney Transplantation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CNI Side Effects
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
527
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2010)
600
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01062555
Other Study ID Numbers  ICMJE 0604M85327
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • Roche Pharma AG
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Genzyme, a Sanofi Company
Investigators  ICMJE
Principal Investigator:Arthur Matas, MDUniversity of Minnesota
PRS Account University of Minnesota
Verification Date February 2018

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