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Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053221
Recruitment Status : Terminated (Funding loss)
First Posted : January 21, 2010
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal allograft function in the absence of long-term calcineurin inhibitors in this fully matched renal transplant cohort.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Mycophenolic Acid Drug: Standard of Care: CNI and MPA Phase 2

Detailed Description:
The objective of the study is to safely move HLA-identical renal transplant recipients from 2 immunosuppressive drugs (calcineurin inhibitor and mycophenolic acid) to mycophenolic acid monotherapy. Safety will be assessed by monitoring renal function in subjects in the withdrawal group compared to those who remain on the standard 2-drug immunosuppression protocol. Results of immunological monitors such as DTH regulation in response to donor minor antigens and development of anti-donor antibodies will be correlated with successful withdrawal.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
Study Start Date : March 2006
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: MPA monotherapy
Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy
Drug: Mycophenolic Acid
Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months
Other Name: cellcept, myfortic

Active Comparator: Control: MPA and CNI
Subjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus)
Drug: Standard of Care: CNI and MPA
Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months

Primary Outcome Measures :
  1. Incidence of Kidney Allograft Rejection and Graft Loss [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Renal Function Measured by Serum Creatinine and eGFR [ Time Frame: 36 months ]
  2. Number of Incidences of Infection and Malignancy [ Time Frame: 36 months ]
    Number of incidences of infection and malignancy will be reported.

  3. Patient Survival [ Time Frame: 36 months ]
    patient survival

  4. Trans-vivo Delayed Type Hypersensitivity (DTH) Assay [ Time Frame: 36 months ]
    Delayed type hypersensitivity (DTH) reactivity status to donor and minor antigens will be detected using trans-vivo DTH assay. This information will help determine if T-regulatory cells are present, and whether such cells predict outcome of Calcineurin inhibitor withdrawal.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects 18-75 years of age.
  • Subjects who are recipients of HLA-identical living donor renal allografts from a sibling and are at least 1 year post transplant, their donors and mothers.
  • Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.

Exclusion Criteria:

  • GFR <40ml/min;
  • diagnosis of SLE,
  • Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount less than this deemed significant on an individual subject basis by the principal investigator),,
  • multi-organ transplant;
  • known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;
  • history of documented post transplant non-compliance with medications, transplant clinic or laboratory follow-up;
  • therapy with an investigational immunosuppressive drug within 6 weeks of study entry;
  • history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
  • patients on less than 500 mg PO BID of CellCept or 360 mg PO BID of Myfortic at the time of potential randomization,
  • history of humoral rejection post transplant,
  • maintenance or for cause treatment with steroids (prednisone) within 3 months of enrollment.

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 identifier (NCT number): NCT01053221

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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: William Burlingham, PhD University of Wisconsin, Madison
Principal Investigator: Hans Sollinger, MD, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison Identifier: NCT01053221     History of Changes
Other Study ID Numbers: H-2005-0357
2012-0343 ( Other Identifier: HS-IRB )
First Posted: January 21, 2010    Key Record Dates
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
living donor
Additional relevant MeSH terms:
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Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents