Chronic Kidney DiseaseGUARDD-US PGxNCT06748040
Genetic Testing to Understand and Address Renal Disease Disparities Across the United States Pharmacogenetic Substudy
A study testing Timing of return of results in people with Chronic Kidney Disease and Hypertension, run by Duke University at 8 sites in United States.
Trial summary
This is a substudy of GUARDD-US (Genetic testing to Understand and Address Renal Disease Disparities across the United States, NCT04191824). Its primary purpose is to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP (systolic blood… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- Timing of return of results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,874 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Jul 2020to 17 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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: A) ICD10 codes (i.e., N18.x; E08.22; E09.22; E10.22; E11.22;E13.22 (exclude Z94.0; N18.6; Z99.2)) OR B) Microalbumin/proteinuria level >30 mg/g for 2 time periods ≥ 3 months. Values taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months of enrollment. OR C) 15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months. GFRs are taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months.
- Diabetes is defined by: HbA1c ≥ 6.5 at least one time in the last year OR ICD10 diagnosis codes OR Having diabetes in the patient's medical record problem list.
Who cannot join
- 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
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- Have had a liver, kidney, or allogeneic 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Florida - Gainesville
Gainesville, Florida, 32610
Eskenazi Health
Indianapolis, Indiana, 46202
Indiana University
Indianapolis, Indiana, 46202
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Institute for Family Health
New York, New York, 10035
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Genetic Testing to Understand and Address Renal Disease Disparities Across the United States - Pharmacogenetic Substudy
This is a substudy of GUARDD-US (Genetic testing to Understand and Address Renal Disease Disparities across the United States, NCT04191824). Its primary purpose is to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP (systolic blood pressure) from baseline to 3 months in APOL1 (apolipoprotein L1) negative individuals at participating sites.
Read the detailed description
GUARDD-US includes a substudy that randomizes participants in the Intervention arm who are from the PGx substudy participating sites and who test negative for APOL1 to PGx Intervention (i.e., immediate PGx ROR) and PGx Control (i.e., delayed PGx ROR) in a 1:1 ratio. This substudy will compare outcomes between participants in the PGx Control group and the PGx Intervention group.
New data show that genetic differences may cause patients to respond differently antihypertensive medication therapy. Pharmacogenomics may help guide initial or add-on antihypertensive therapy management. However, the impact of PGx testing on BP has not been studied in clinical trials among general or African ancestry populations.
Population for PGx Substudy:
Participants from Randomized Population who are randomized to Intervention and who test negative for APOL1. Only participants from PGx-substudy participating sites are included in this population.
Substudy Analyses:
Major primary 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).
- Conditions
- Chronic Kidney Disease, Hypertension
- Being tested
- Timing of return of results
- Keywords
- Kidney Disease, Genetic testing, Pharmacogenomics, Hypertensive medications
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of return of resultsOther
Participants will be randomized to immediate versus delayed return of PGx results.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Return of Results | Active comparator | Immediate return of pharmacogenetic (PGx) results to substudy (APOL1 negative) participant. Receives: Other: Timing of return of results |
| Delayed Return of Results | Active comparator | Delayed return of pharmacogenetic (PGx) results to substudy (APOL1 negative) participant until after the completion of the 6 month final study visit. Receives: Other: Timing of return of results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Negative Participants
Measured: Baseline to 3 month study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start10 Jul 2020
- Primary completion9 Apr 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Immediate versus delayed return of pharmacogenetics (PGx) testing results to provider and participant.
- Masking
- None (open label)
- Enrolment
- 1,874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), Icahn School of Medicine at Mount Sinai, University of Florida, Indiana University
- Responsible party
- Sponsor
- Investigators
- Hrishikesh Chakraborty, DrPH, Study director, Duke UniversityCarol Horowitz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748040
- Sponsor's protocol ID
- Pro00102997_A
- Other IDs
- U01HG010225, U01HG007269, U01HG010248, U01HG010245
- Acronym
- GUARDD-US PGx
- Status last verified
- Apr 2025
- First submitted
- 19 Dec 2024
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Data Coordinating Center (DCC) will submit de-identified participant level datasets and associated documentation to the NHGRI's data repository - Genomic Analysis, Visualization and Informatics Lab-space (AnVIL), for use by other investigators. The datasets and associated documentation will be available after publication of the primary results manuscript. Documentation will include annotated case report forms, list of derived variables along with descriptions, and a description of the data model and de-identification process. The substudy data will be submitted within the main study complete dataset.
Publications
Eadon MT, Cavanaugh KL, Orlando LA, Christian D, Chakraborty H, Steen-Burrell KA, Merrill P, Seo J, Hauser D, Singh R, Beasley CM, Fuloria J, Kitzman H, Parker AS, Ramos M, Ong HH, Elwood EN, Lynch SE, Clermont S, Cicali EJ, Starostik P, Pratt VM, Nguyen KA, Rosenman MB, Calman NS, Robinson M, Nadkarni GN, Madden EB, Kucher N, Volpi S, Dexter PR, Skaar TC, Johnson JA, Cooper-DeHoff RM, Horowitz CR; GUARDD-US Investigators. Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension. Contemp Clin Trials. 2022 Aug;119:106813. doi: 10.1016/j.cct.2022.106813. Epub 2022 Jun 1.
PubMed 35660539
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Testing to Understand and Address Renal Disease Disparities Across the United States - Pharmacogenetic Substudy
- ClinicalTrials.gov ID
- NCT06748040
- Acronym / sponsor ID
- GUARDD-US PGx / Pro00102997_A
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- Kidney Disease, Genetic testing, Pharmacogenomics, Hypertensive medications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,874 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), Icahn School of Medicine at Mount Sinai, University of Florida, Indiana University
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a substudy of GUARDD-US (Genetic testing to Understand and Address Renal Disease Disparities across the United States, NCT04191824). Its primary purpose is to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP (systolic blood pressure) from baseline to 3 months in APOL1 (apolipoprotein L1) negative individuals at participating sites.
Detailed description
GUARDD-US includes a substudy that randomizes participants in the Intervention arm who are from the PGx substudy participating sites and who test negative for APOL1 to PGx Intervention (i.e., immediate PGx ROR) and PGx Control (i.e., delayed PGx ROR) in a 1:1 ratio. This substudy will compare outcomes between participants in the PGx Control group and the PGx Intervention group.
New data show that genetic differences may cause patients to respond differently antihypertensive medication therapy. Pharmacogenomics may help guide initial or add-on antihypertensive therapy management. However, the impact of PGx testing on BP has not been studied in clinical trials among general or African ancestry populations.
Population for PGx Substudy:
Participants from Randomized Population who are randomized to Intervention and who test negative for APOL1. Only participants from PGx-substudy participating sites are included in this population.
Substudy Analyses:
Major primary 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Immediate versus delayed return of pharmacogenetics (PGx) testing results to provider and participant.
| Arm | Type | Receives |
|---|---|---|
| Immediate Return of Results | Active comparator | Other: Timing of return of resultsImmediate return of pharmacogenetic (PGx) results to substudy (APOL1 negative) participant. |
| Delayed Return of Results | Active comparator | Other: Timing of return of resultsDelayed return of pharmacogenetic (PGx) results to substudy (APOL1 negative) participant until after the completion of the 6 month final study visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Self reported African ancestry
- English Speaking
- Age 18-70 years
- Have diagnosis of hypertension: Diagnosis of hypertension is defined by either:
- Have been seen at ≥1 time in past year at a participating primary care site
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of return of resultsParticipants will be randomized to immediate versus delayed return of PGx results. | Other | Delayed Return of Results, Immediate Return of Results |
Primary outcome
Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Negative Participants
Time frame: Baseline to 3 month study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35660539Eadon MT, Cavanaugh KL, Orlando LA, Christian D, Chakraborty H, Steen-Burrell KA, Merrill P, Seo J, Hauser D, Singh R, Beasley CM, Fuloria J, Kitzman H, Parker AS, Ramos M, Ong HH, Elwood EN, Lynch SE, Clermont S, Cicali EJ, Starostik P, Pratt VM, Nguyen KA, Rosenman MB, Calman NS, Robinson M, Nadkarni GN, Madden EB, Kucher N, Volpi S, Dexter PR, Skaar TC, Johnson JA, Cooper-DeHoff RM, Horowitz CR; GUARDD-US Investigators. Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension. Contemp Clin Trials. 2022 Aug;119:106813. doi: 10.1016/j.cct.2022.106813. Epub 2022 Jun 1.
- Individual participant dataSharing planned: Yes. The Data Coordinating Center (DCC) will submit de-identified participant level datasets and associated documentation to the NHGRI's data repository - Genomic Analysis, Visualization and Informatics Lab-space (AnVIL), for use by other investigators. The datasets and associated documentation will be available after publication of the primary results manuscript. Documentation will include annotated case report forms, list of derived variables along with descriptions, and a description of the data model and de-identification process. The substudy data will be submitted within the main study complete dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hrishikesh Chakraborty, DrPH study director
Duke University
Carol Horowitz, MD principal investigator
Icahn School of Medicine at Mount Sinai
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of return of results in people with Chronic Kidney Disease and Hypertension, run by Duke University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Negative Participants (time frame: Baseline to 3 month study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.