Evaluation of APOL1 Gene Variants in Kidney Donors and Their Impact on Long-term Renal Function in Donors and Recipients

NCT06116721 | Recruiting

• 1 other identifier: Hospital do Rim - FOR
• Study Type: observational
• Target: 2,450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Diseases; Transplant Failure

Keywords

APOL1 gene; Kidney transplantation; Living donor; Kidney function; Kidney graft survival

Outcome Measures

Primary Outcomes (1)

• For evaluation of living donor kidney transplant recipients

  It will be a longitudinal, observational, retrospective cohort study. Adult kidney transplant recipients from a living donor will be included, who have performed the transplant at the Hospital do Rim in the period between January 1, 2008 and March 31, 2015, who remained alive and with a functioning graft one year after the transplant. The observation time will be until March 2020, so that all recipients have had the opportunity to complete at least 5 years of follow-up after transplantation

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1.1.2.For evaluation of living donor kidney transplant recipients It will be a longitudinal, observational, retrospective cohort study. Adult kidney transplant recipients from a living donor will be included, who have performed the transplant at the Hospital do Rim in the period between January 1, 2008 and March 31, 2015, who remained alive and with a functioning graft one year after the transplant. The observation time will be until March 2020, so that all recipients have had the opportunity to complete at least 5 years of follow-up after transplantation.

You may qualify if:

• Living donor kidney transplant recipients, performed at Hospital do Rim from January 1, 2008 to March 31, 2015;
• Recipients Who have reached one year after the transplant, with a functioning renal graft;
• 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:
• Living kidney donors whose donation was made at the Hospital do Rim in the period between January 2008 and December 2015;
• That they are alive at the time the study begins;
• Who have signed the TCLE.

You may not qualify if:

• For recipients:
• Recipients who have undergone the transplant under the age of 18 years;
• 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.

Sponsors & Collaborators

• Hospital do Rim e Hipertensão: lead

Study Sites (1)

Hospital do Rim

São Paulo, São Paulo, 04038-002, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

High-risk variants of the APOL1 gene: they are homozygous (G1 / G1 or G2 / G2) and compound heterozygous (G1 / G2) forms.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Melissa Gaspar Tavares

  Medical Physician

  STUDY DIRECTOR

• Helio Tedesco Silva Junior

  Doctor of Renal Transplant Unit

  PRINCIPAL INVESTIGATOR

• Mônica Rika Nakamura

  Study coordinator

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: October 15, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)