Evaluating the impact of APOL1 gene variants on kidney function in donors and recipients

Evaluation of the Frequency of APOL1 Gene Variants in Kidney Donors and the Impact of These Variants on the Long-term Renal Function of Kidney Transplant Donors and Recipients

This study is testing how certain gene variations related to kidney function affect both kidney donors and recipients, especially focusing on those of African ancestry.

Quick facts

• Study type: Observational
• Enrollment: 2450 (estimated)
• Sex: All
• Sponsor: Hospital do Rim e Hipertensão (other)
• Locations: 1 site (São Paulo, SP)
• Trial ID: NCT06116721 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the frequency of APOL1 gene variants in kidney donors and examines how these variants affect long-term renal function in both donors and recipients. It focuses on living donor kidney transplant recipients at the Hospital do Rim in São Paulo, Brazil, who have had functioning renal grafts for at least one year. The study aims to understand the relationship between genetic factors and kidney transplant outcomes, particularly in individuals of African ancestry, who may have a higher risk of chronic kidney disease due to these variants.

Who should consider this trial

Good fit: Ideal candidates include living kidney donors and recipients who had transplants at the Hospital do Rim between 2008 and 2015 and have provided informed consent.

Not a fit: Patients who are under 18 years old or have previously undergone transplantation of other organs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved kidney transplant outcomes by identifying genetic risk factors that affect graft survival.

How similar studies have performed: While the study focuses on a specific genetic variant in a unique population, similar studies have indicated that genetic factors can significantly impact transplant outcomes, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1.1.1.1. Inclusion criteria 1.1.1.2. For recipients:

1. Living donor kidney transplant recipients, performed at Hospital do Rim from January 1, 2008 to March 31, 2015;
2. Recipients Who have reached one year after the transplant, with a functioning renal graft;
3. Recipients whose donors were located agreed to participate in the research, signed the informed consent form (TCLE) and submitted to the collection of exams.

For donors:

1. Living kidney donors whose donation was made at the Hospital do Rim in the period between January 2008 and December 2015;
2. That they are alive at the time the study begins;
3. Who have signed the TCLE.

Exclusion Criteria:

* For recipients:

  1. Recipients who have undergone the transplant under the age of 18 years;
  2. Recipients who have previously undergone transplantation of other organs; 1.1.3.3. For donors: Donors Who withdraw the informed consent form at any stage of the study.

Where this trial is running

São Paulo, SP

• Hospital do Rim — São Paulo, SP, Brazil (RECRUITING)

Study contacts

• Principal investigator: Helio Tedesco Silva Junior — Doctor of Renal Transplant Unit

Conditions: Kidney Diseases, Transplant Failure, APOL1 gene, Kidney transplantation, Living donor, Kidney function, Kidney graft survival