Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Recruiting
Phase 4
Interventional Study
Disorder Related to Renal Transplantation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Other
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About This Trial
In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.
Exclusion Criteria:
* Obese patients (body mass index above 35 m2);
* History of GESF or membranoproliferative glomerulonephritis (MPGN) as …
Contacts
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