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

Kidney Transplantation Clinical Trial

Official title:

Evaluation of the Effects of Sirolimus Addition to the Triple Immunosuppression Protocol on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Sensitized Kidney Transplant Recipients - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02208791
• Other study ID #: U1111-1157-7462
• Status: Recruiting
• Phase: Phase 4
• First received: August 1, 2014
• Last updated: December 15, 2015
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: June 2014
• Source: University of Sao Paulo General Hospital
• Contact: Nelson Z Galante, PhD
• Phone: 55-11-2661-8089
• Email: nelson.galante[@]hc.fm.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• 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.
• No intervention

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of graft loss and/or death with graft function		up to one year	Yes
Secondary	Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection		Up to one year	Yes