Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant

NCT02208791 | Unknown Phase 4 DMC

• 1 other identifier: U1111-1157-7462
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Graft Rejection; Immunossupression

Outcome Measures

Primary Outcomes (1)

• A composite of graft loss and/or death with graft function

  up to one year

Secondary Outcomes (1)

• Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection

  Up to one year

Study Arms (2)

Tacrolimus/MPS/Prednisone

ACTIVE COMPARATOR

This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm

Drug: No intervention

Sirolimus/Low Tacrolimus/MPS/Prednisone

EXPERIMENTAL

Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid..

Drug: Sirolimus

Interventions

Sirolimus DRUG

Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.

Sirolimus/Low Tacrolimus/MPS/Prednisone

No intervention DRUG

Tacrolimus/MPS/Prednisone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, ages 18 to 60 years inclusive
• Percentage of Panel Reactive Antibodies at transplantation \> 20%

You may not qualify if:

• Subjects with a history of cancer
• Subjects with a previous non kidney transplantation
• Subjects receiving any immunosuppression different of tacrolimus/prednisone/mycophenolate
• Subjects with a urinary protein/creatinine ratio greater than 0.3
• Subjects with active HBV, HCV and HIV infection

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Nelson Z Galante, PhD

CONTACT

55-11-2661-8089; nelson.galante@hc.fm.usp.br

Fabiana Agena, MS

CONTACT

55-11-2661-8089; fabiana.agena@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: December 16, 2015

Record last verified: 2014-06

Locations

BR (1)