NCT06584773 Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
| NCT ID | NCT06584773 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Disorder Related to Renal Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2015-06 |
| Primary Completion | 2024-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2015-06 with a primary completion date of 2024-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 primary cause of renal failure; * Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus; * Triglyceride levels greater than 300 mg/dl at enrollment; * Active infection by hepatitis B virus, hepatitis C virus or HIV; * CMV nonreactive IgG sorology at the time of transplantation.
Frequently Asked Questions
Who can join the NCT06584773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Disorder Related to Renal Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06584773 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06584773 currently recruiting?
Yes, NCT06584773 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Sao Paulo General Hospital to inquire about joining.
Where is the NCT06584773 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06584773 clinical trial?
NCT06584773 is sponsored by University of Sao Paulo General Hospital. The trial plans to enroll 80 participants.