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Genetic Testing to Understand and Address Renal Disease Disparities

NCT02234063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2052

Last updated 2020-10-05

Study results available
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Summary

In this genomic medicine implementation pilot project, the investigators aim to conduct a randomized trial in a network of community health centers and primary care facilities to study processes, effects and challenges of incorporating information for apolipoprotein L1 (APOL1)-attributable genetic risk for end stage kidney disease in patients of African ancestry with hypertension .

Conditions

Interventions

OTHER

Immediate Genetic Testing

Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.

Sponsors & Collaborators

Principal Investigators

  • Erwin Bottinger, MD, MPH · Icahn School of Medicine at Mount Sinai

  • Carol R Horowitz, MD, MPH · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-01-12
Completion
2018-01-12

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234063 on ClinicalTrials.gov