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OpenTrials
Completed

NCT Number: NCT02234063

Genetic Testing to Understand and Address Renal Disease Disparities

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 .

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai, New York, United States

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About this study

CKD is most commonly associated with diabetes (40%) and hypertension (28%), and affects 26 million American adults. African ancestry populations with hypertension (HTN) have 2- to 3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage renal disease (ESRD) when compared with whites. HTN is a risk factor for progression of CKD and for increased cardiovascular risk with CKD. Thus targeting blood pressure control as a modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD to end stage disease. Recent discoveries demonstrate that testable alleles of the APOL1 locus on chromosome 22 have a major effect on and explain almost all of the excess risk for hypertension-associated CKD and its progression to ESRD in African ancestry populations.

We will use community-engaged approaches to enroll patients of African Ancestry with HTN from a network of community health centers and primary care facilities in Harlem and the Bronx and randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider clinical decision support incorporating APOL1 genomic risk information.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages18-65
  • Self-identifies as Black/African American
  • History of hypertension
  • Patient at a participating site

Exclusion criteria

  • History of Chronic Kidney Disease
  • History of Diabetes
  • Pregnant
  • Cognitively impaired/unable to provide consent
  • Terminally ill
  • Planning to leave area of study permanently during the one year study period

Treatment and study plan

Immediate Genetic Testing

Other

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.

Other names: Genetic Risk Communication

Primary outcomes

  1. Number of Participants With Urine Protein Excretion

    Time frame: Baseline and 12 months

    Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline

  2. Change in Systolic Blood Pressure

    Time frame: Baseline and 3 months

    Change in systolic blood pressure at 3 months as compared to baseline

Secondary outcomes

  1. Number of Participants With Change in Medication Adherence

    Time frame: 3 months

    Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization

  2. Number of Patients With Changes in Psychosocial Behaviors

    Time frame: 3 months

    Number of patients with changes in psychosocial behaviors 3 months after randomization

  3. Number of Participants With Attitude Towards Genetic Testing

    Time frame: 3 months

    Patient attitude towards genetic testing 3 months after randomization

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care

Acronym: GUARDD

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2014
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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