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Trial record 1 of 1 for:    GUARDD-US | United States
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Genetic Testing to Understand and Address Renal Disease Disparities Across the United States (GUARDD-US)

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ClinicalTrials.gov Identifier: NCT04191824
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : April 24, 2023
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:

The primary aim is to determine the effect of participant and provider knowledge of a positive APOL1 status and accompanying guideline based clinical decision support (CDS) on blood pressure management on change in systolic blood pressure (SBP) from baseline to 3 months after randomization among the APOL1 positive participants. Secondary aims are to:

  1. Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of appropriate CKD diagnosis.
  2. Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of receiving a urine microalbumin/creatinine testing and ACE-I/ARB prescription based on results of the urine microalbumin level.
  3. Explore cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of participant and provider knowledge of APOL1 status on provider treatment recommendations.

PGX Substudy

In addition, GUARDD-US will include a substudy to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP from baseline to 3 months in APOL1 negative individuals.

Approximately 6,650 participants of African ancestry age 18-70 with hypertension that either: 1) do not have diabetes and do not have CKD, or 2) have CKD. Participants with diabetes may be included as long as they also have CKD.

Population for Main Study:

Participants from Randomized Population (above) who test positive for APOL1

Population for PGx Substudy:

Participants from Randomized Population (above) randomized to Intervention and who test negative for APOL1

Main Study Analyses:

  • To determine the effect of participant and provider knowledge of a positive APOL1 status on SBP, we will compare the change in SBP from baseline to 3 months of the Intervention - APOL1 positive group to the change in SBP from baseline to 3 months of the Control - APOL1 positive group using a two sided t-test, as appropriate, with a two-sided type I error of 0.05.
  • The effect of knowledge of a positive APOL1 status on all secondary endpoints will be compared between Intervention - APOL1 positives to Control - APOL1 positives with the proportion difference test.
  • Additional analyses will include analysis of time trends in SBP, subset analyses, and exploratory analyses of cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of knowledge of APOL1 status on provider treatment recommendations.

Substudy Analyses:

All primary and secondary endpoint analyses conducted for the APOL1 main study will be repeated for the PGx substudy focusing on differences in outcomes between APOL1 negative individuals with immediate PGx ROR (PGx Intervention) and APOL1 negative individuals with delayed PGx ROR (PGx Control).


Condition or disease Intervention/treatment Phase
Renal Disease Diagnostic Test: APOL1 status Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Immediate versus delayed return of Apolipoprotein L1 (APOL1) gene testing results to provider and participant.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Immediate Return of Results
Immediate return of results to inform participant of APOL1 status (either positive or negative).
 Diagnostic Test: APOL1 status
Participants will be randomized to immediate versus delayed return of results for positive or negative APOL1 status.
Active Comparator: Delayed Return of Results
Delayed return of results of APOL1 status (either positive or negative) after the completion of the 6 month final study visit.
 Diagnostic Test: APOL1 status
Participants will be randomized to immediate versus delayed return of results for positive or negative APOL1 status.


Outcome Measures
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Primary Outcome Measures :
  1. Change in systolic blood pressure from baseline to 3 months [ Time Frame: Baseline to 3 month study visit ]
    Change in systolic blood pressure


Secondary Outcome Measures :
  1. Change in urine microalbuminuria/proteinuria [ Time Frame: From baseline to 6 months ]
    Change in urine microalbuminuria/proteinuria

  2. Appropriate order of microalbuminuria/proteinuria tests [ Time Frame: baseline to 6 months ]
    Appropriate order of microalbuminuria/proteinuria tests

  3. Change in appropriate diagnosis for stage 3 CKD [ Time Frame: baseline to 6 months ]
    Change in appropriate diagnosis for stage 3 CKD

  4. Appropriate diagnosis of CKD stage 3 and above [ Time Frame: baseline to 6 months ]
    Appropriate diagnosis of CKD stage 3 and above

  5. Change in appropriate diagnosis for any stage CKD [ Time Frame: Baseline to 6 months ]
    Change in appropriate diagnosis for any stage CKD

  6. Appropriate diagnosis of all stage CKD [ Time Frame: Baseline to 6 months ]
    Appropriate diagnosis of all stage CKD


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self reported African ancestry
  • English Speaking
  • Age 18-70 years
  • Have diagnosis of hypertension

Diagnosis of hypertension is defined by either:

  • ICD10 diagnosis codes (i.e., I10; I11.x; I12.x; I13.x; I16.x) OR
  • On active antihypertensive therapy for indication of hypertension OR
  • Having systolic blood pressure of 140 mm Hg or greater in at least 2 of the last 3 consecutive recorded values in the EHR OR

  • Having hypertension in the patient's medical record problem list

    • Have been seen at ≥1 time in past year at a participating primary care site
    • Either: 1) do not have diabetes and do not have CKD, or 2) have CKD;

Participants with diabetes may be included as long as they also have CKD.

  • CKD is defined by either:

    1) ICD10 codes (i.e., N18.x; E08.22; E09.22; E10.22; E11.22;E13.22 (exclude Z94.0; N18.6; Z99.2)) OR

  • 15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months
  • Diabetes is defined by:
  • HbA1c ≥ 6.5 at least one time in the last year OR
  • ICD10 diagnosis codes (see Appendix A) OR
  • Having diabetes in the patient's medical record problem list

Exclusion Criteria:

  • Have diabetes, but no CKD.
  • Are currently on dialysis (ICD 10 codes N18.6, Z99.2 and Z94.0)
  • Have ESRD (eGFR<15 ml/min)
  • Have a left ventricular assist device (LVAD)
  • Have a terminal illness
  • Have patient-reported known pregnancy at time of enrollment
  • Have had a liver, kidney, or bone marrow transplant
  • Too cognitively impaired to provide informed consent and/or complete the study protocol
  • Institutionalized or too ill to participate (i.e. incarcerated, psychiatric or nursing home facility)
  • Plan to move out of the area within 6 months of enrollment
  • Not a current patient seeing a provider who cares for their hypertension (i.e., family medicine, internal medicine, nephrology, HIV provider, cardiology, hypertension specialists) at a participating site
  • Previously participated in the GUARDD pilot study OR have previously undergone APOL1 testing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191824


Contacts
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Contact: Kady-Ann Steen-Burrell 919-530-9711 kady.ann.steen.burrell@duke.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Stephanie Ford       sledbetter@uabmc.edu   
Principal Investigator: Nita Limdi, Pharm.D, Ph.D.         
United States, Florida
University of Florida - Gainesville Active, not recruiting
Gainesville, Florida, United States, 32610
University of Florida - Jacksonville Active, not recruiting
Jacksonville, Florida, United States, 32209
United States, Indiana
Eskenazi Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Stuart       jschafft@iu.edu   
Principal Investigator: Michael Eadon, MD         
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Stuart       jschafft@iu.edu   
Principal Investigator: Michael Eadon, MD         
United States, Louisiana
University Medical Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Domnic Betts       Domnic.Bett@lcmchealth.org   
Principal Investigator: Jyotsna Fuloria, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Michelle Ramos    212-659-9571    michelle.ramos@mountsinai.org   
Principal Investigator: Carol Horowitz, MD         
The Institute for Family Health Recruiting
New York, New York, United States, 10035
Contact: Nandini Shroff    212-633-0800 ext 1363    Nshroff@institute.org   
Principal Investigator: Neil Calman, MD         
United States, North Carolina
Southeastern Healthcare Active, not recruiting
Lumberton, North Carolina, United States, 28358
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Linda Prebehalla    412-849-0773    lprebeh@pitt.edu   
Principal Investigator: Philip Empey, PharmD, PhD         
United States, Tennessee
Meharry Medical College Recruiting
Nashville, Tennessee, United States, 37208
Contact: Sara Block    615-327-6204    sara.block@vumc.org   
Principal Investigator: Rajbir Singh, MD         
Nashville General Hospital Recruiting
Nashville, Tennessee, United States, 37208
Contact: Sara Block    615-327-6204    sara.block@vumc.org   
Principal Investigator: Rajbir Singh, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sara Block    615-322-5000    sara.block@vumc.org   
Principal Investigator: Kerri Cavanaugh, MD         
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75210
Contact: Joycelyn Larbie       Joycelyn.Larbie@BSWHealth.org   
Principal Investigator: Heather Kitzman, MD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Hrishikesh Chakraborty Duke University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04191824    
Other Study ID Numbers: PRO00102997
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases