Using a quadruple immunosuppressor regimen for sensitized kidney transplant patients
Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
This study is testing a new combination of four medications to see if it helps kidney transplant patients who are at higher risk of rejection due to their immune system being more sensitive.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06584773 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of a quadruple immunosuppressor regimen that includes sirolimus in sensitized renal transplant recipients who are at a higher risk of acute rejection. The participants will receive a combination of sirolimus, tacrolimus, mycophenolate, and prednisone to assess the potential benefits of this enhanced immunosuppression approach. The study aims to determine if this regimen can improve transplant outcomes in patients with a panel of reactive antibodies (PRA) greater than 30%. By focusing on sensitized patients, the research seeks to address a significant challenge in kidney transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are sensitized renal transplant recipients with a PRA greater than 30% who can provide informed consent.
Not a fit: Patients who are obese, have specific renal failure causes, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved transplant outcomes and reduced rates of acute rejection in sensitized kidney transplant patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing immunosuppression for sensitized transplant patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- Renal Transplantation Service — São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.