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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01053221
First received: January 19, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention
Kidney Transplantation
Drug: Mycophenolic Acid
Drug: Standard of Care: CNI and MPA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Incidence of kidney allograft rejection and graft loss [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Renal function measured by serum creatinine and eGFR [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • incidence of infection and malignancy [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • patient survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • DTH reactivity to donor and minor antigens [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01053221

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01053221     History of Changes
Other Study ID Numbers: H-2005-0357
Study First Received: January 19, 2010
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
mycophenolate
living donor

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014