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

Phase 4

• Conditions: Kidney Transplantation
• Interventions: Drug: Sirolimus; Drug: No intervention

• Registration Number: NCT02208791
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-07
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16
• Primary Completion: 2016-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Men and women, ages 18 to 60 years inclusive
• Percentage of Panel Reactive Antibodies at transplantation > 20%
• Estimated glomerular filtration rate using MDRD formula at inclusion >29ml/min

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus/Low Tacrolimus/MPS/Prednisone	Sirolimus	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..
Tacrolimus/MPS/Prednisone	No intervention	This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm

Primary Outcome Measures

Name	Time	Method
A composite of graft loss and/or death with graft function	up to one year

Secondary Outcome Measures

Name	Time	Method
Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection	Up to one year

Trial Locations

Locations (1)

Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 Sao Paulo, Brazil