Recruiting PHASE4 Disorder Related to Renal Transplantation

Tests treatment safety and results for Disorder Related to Renal Transplantation

Official title Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients

ClinicalTrials.gov ID: NCT06584773

What this study is testing

What is Everolimus?

Everolimus is an investigational medicine, being studied as a potential treatment for disorder related to renal transplantation.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 60

You may be able to join if

  • Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • São Paulo, Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.