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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01053221
• Other study ID #: H-2005-0357
• Secondary ID: 2012-0343
• Status: Terminated
• Phase: Phase 2
• Start date: March 2006
• Est. completion date: August 2012

Study information

• Verified date: June 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Mycophenolic Acid
Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Kidney Allograft Rejection and Graft Loss		36 months
Secondary	Renal Function Measured by Serum Creatinine and eGFR		36 months
Secondary	Number of Incidences of Infection and Malignancy	Number of incidences of infection and malignancy will be reported.	36 months
Secondary	Patient Survival	patient survival	36 months
Secondary	Trans-vivo Delayed Type Hypersensitivity (DTH) Assay	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.	36 months