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NCT04910867 · ClinicalTrials.gov registry record · NA

APOL1 Genetic Testing Program for Living Donors

A NA study of Chronic Kidney Diseases and Kidney Transplantation, sponsored by Northwestern University.

Active
Registry status
NA
Development phase
206
Enrollment target
2
Study locations

NCT04910867 is a NA study of Chronic Kidney Diseases and Kidney Transplantation that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 206 participants, below the 442-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04910867, a NA study of Chronic Kidney Diseases and Kidney Transplantation, is active but no longer recruiting, sponsored by Northwestern University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
206 participants
Enrollment target
2
Study locations

Study Summary

Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating. No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1 is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1 testing program for AA LDs at two transplant centers serving large AA

Interventions

  • BEHAVIORAL Components of Genetic Counseling
  • DIAGNOSTIC_TEST APOL1 genetic testing
  • OTHER EHR integration

Study Locations (2)

District of Columbia

  • Medstar Georgetown Transplant Institute - Washington D.C.

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2021-09-09
Est. Completion 2026-03-31
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT04910867

The ClinicalTrials.gov registry entry for NCT04910867 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 442-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (53% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 3 interventions - of which Components of Genetic Counseling is the first listed.

NCT04910867 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Illinois.

Frequently Asked Questions

What is clinical trial NCT04910867 about?

NCT04910867 is a clinical study titled "APOL1 Genetic Testing Program for Living Donors". Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence sug...

What is the current status of trial NCT04910867?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 206 participants. The study started on 2021-09-09. Estimated completion is 2026-03-31.

What conditions does trial NCT04910867 study?

This clinical trial studies the following conditions: Chronic Kidney Diseases, Kidney Transplantation, Apolipoprotein L1.

What interventions are being tested in trial NCT04910867?

The interventions under investigation include: Components of Genetic Counseling (BEHAVIORAL), APOL1 genetic testing (DIAGNOSTIC_TEST), EHR integration (OTHER).

Who is sponsoring clinical trial NCT04910867?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04910867 being conducted?

This trial has 2 study locations across District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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