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

NCT01053221 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: H-2005-03572012-0343
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

mycophenolate; living donor

Outcome Measures

Primary Outcomes (1)

• Incidence of Kidney Allograft Rejection and Graft Loss

  36 months

Secondary Outcomes (4)

• Renal Function Measured by Serum Creatinine and eGFR

  36 months

• Number of Incidences of Infection and Malignancy

  36 months

• Patient Survival

  36 months

• Trans-vivo Delayed Type Hypersensitivity (DTH) Assay

  36 months

Study Arms (2)

MPA monotherapy

EXPERIMENTAL

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

Drug: Mycophenolic Acid

Control: MPA and CNI

ACTIVE COMPARATOR

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

Interventions

Mycophenolic Acid DRUG

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

Also known as: cellcept, myfortic

MPA monotherapy

Standard of Care: CNI and MPA 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

Control: MPA and CNI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: William Burlingham, PhD
• Organization: University of Wisconsin-Madison

burlingham@surgery.wisc.edu

6082630119

Study Officials

• William Burlingham, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Hans Sollinger, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: March 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-06

Locations

US (1)