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

NCT ID: NCT01053221

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-08-31

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.

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MPA monotherapy

Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy

Group Type: EXPERIMENTAL

Mycophenolic Acid

Intervention Type: DRUG

Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months

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)

Group Type: ACTIVE_COMPARATOR

Standard of Care: CNI and MPA

Intervention Type: DRUG

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

Interventions

Mycophenolic Acid

Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

cellcept, myfortic

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Burlingham, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Hans Sollinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2012-0343

Identifier Type: OTHER

Identifier Source: secondary_id

H-2005-0357

Identifier Type: -

Identifier Source: org_study_id