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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02208791

Enrollment

Registered

2014-08-05

Start date

2014-07-31

Completion date

2017-07-31

Last updated

2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation, Graft Rejection, Immunossupression

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.

Interventions

DRUGSirolimus

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.

DRUGNo intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Contacts

Primary ContactNelson Z Galante, PhD

nelson.galante@hc.fm.usp.br55-11-2661-8089

Backup ContactFabiana Agena, MS

fabiana.agena@hc.fm.usp.br55-11-2661-8089

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026