Trial Outcomes & Findings for Genetic Testing to Understand and Address Renal Disease Disparities Across the United States (NCT NCT04191824)
NCT ID: NCT04191824
Last Updated: 2025-04-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6789 participants
Primary outcome timeframe
Baseline to 3 month study visit
Results posted on
2025-04-30
Participant Flow
Participants were recruited by providers who care for participants with hypertension (including, for example, general internists, primary care providers, and nephrologists).
There were 6789 participants consented into the overall GUARDD-US trial. Of the 6789, 35 consented participants were not randomized into the trial and were not assigned to a treatment arm. The remaining 6754 consented participants were randomized and assigned into the treatment arms. The 6754 randomized participants will be described moving forward.
Participant milestones
| Measure |
Immediate Return of Results
Immediate return of results to inform participant of APOL1 status (either positive or negative).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3380
|
3374
|
|
Overall Study
COMPLETED
|
2869
|
2884
|
|
Overall Study
NOT COMPLETED
|
511
|
490
|
Reasons for withdrawal
| Measure |
Immediate Return of Results
Immediate return of results to inform participant of APOL1 status (either positive or negative).
|
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.
|
|---|---|---|
|
Overall Study
Death
|
13
|
12
|
|
Overall Study
Lost to Follow-up
|
456
|
435
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
16
|
18
|
|
Overall Study
Early site closure
|
24
|
22
|
Baseline Characteristics
Intent to Treat population
Baseline characteristics by cohort
| Measure |
Immediate Return of Results
n=3380 Participants
Immediate return of results to inform participant of APOL1 status (either positive or negative).
|
Delayed Return of Results
n=3374 Participants
Delayed return of results of APOL1 status (either positive or negative) after the completion of the 6 month final study visit.
|
Total
n=6754 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 9.9 • n=486 Participants • Modified Intent to Treat population
|
55.1 years
STANDARD_DEVIATION 10.1 • n=468 Participants • Modified Intent to Treat population
|
54.9 years
STANDARD_DEVIATION 10.0 • n=954 Participants • Modified Intent to Treat population
|
|
Sex: Female, Male
Female
|
326 Participants
n=486 Participants • Modified Intent to Treat population
|
274 Participants
n=468 Participants • Modified Intent to Treat population
|
600 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Sex: Female, Male
Male
|
160 Participants
n=486 Participants • Modified Intent to Treat population
|
194 Participants
n=468 Participants • Modified Intent to Treat population
|
354 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=486 Participants • Modified Intent to Treat population
|
8 Participants
n=468 Participants • Modified Intent to Treat population
|
11 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
478 Participants
n=486 Participants • Modified Intent to Treat population
|
457 Participants
n=468 Participants • Modified Intent to Treat population
|
935 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=486 Participants • Modified Intent to Treat population
|
3 Participants
n=468 Participants • Modified Intent to Treat population
|
8 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=486 Participants • Modified Intent to Treat population
|
2 Participants
n=468 Participants • Modified Intent to Treat population
|
2 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=486 Participants • Modified Intent to Treat population
|
0 Participants
n=468 Participants • Modified Intent to Treat population
|
0 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=486 Participants • Modified Intent to Treat population
|
1 Participants
n=468 Participants • Modified Intent to Treat population
|
2 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
457 Participants
n=486 Participants • Modified Intent to Treat population
|
428 Participants
n=468 Participants • Modified Intent to Treat population
|
885 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · White
|
0 Participants
n=486 Participants • Modified Intent to Treat population
|
0 Participants
n=468 Participants • Modified Intent to Treat population
|
0 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · North African/Mediterranean
|
1 Participants
n=486 Participants • Modified Intent to Treat population
|
0 Participants
n=468 Participants • Modified Intent to Treat population
|
1 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · More than one race
|
17 Participants
n=486 Participants • Modified Intent to Treat population
|
28 Participants
n=468 Participants • Modified Intent to Treat population
|
45 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
10 Participants
n=486 Participants • Modified Intent to Treat population
|
9 Participants
n=468 Participants • Modified Intent to Treat population
|
19 Participants
n=954 Participants • Modified Intent to Treat population
|
|
Region of Enrollment
United States
|
3380 Participants
n=3380 Participants
|
3374 Participants
n=3374 Participants
|
6754 Participants
n=6754 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 month study visitPopulation: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).
Outcome measures
| Measure |
Immediate Return of Results (Modified Intent to Treat, mITT)
n=446 Participants
Immediate return of results to APOL1 positive participants.
|
Delayed Return of Results (Modified Intent to Treat, mITT)
n=428 Participants
Delayed return of results to APOL1 positive participants after the completion of the 6 month final study visit.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Positive Participants.
|
-1.8 mmHg
Standard Deviation 18.8
|
-1.5 mmHg
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Baseline to 6 month study visitPopulation: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).
Outcome measures
| Measure |
Immediate Return of Results (Modified Intent to Treat, mITT)
n=473 Participants
Immediate return of results to APOL1 positive participants.
|
Delayed Return of Results (Modified Intent to Treat, mITT)
n=454 Participants
Delayed return of results to APOL1 positive participants after the completion of the 6 month final study visit.
|
|---|---|---|
|
Change in Number of Participants With Urine Microalbuminuria/Proteinuria Orders
|
95 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: From baseline to 6 month study visitPopulation: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).
Outcome measures
| Measure |
Immediate Return of Results (Modified Intent to Treat, mITT)
n=473 Participants
Immediate return of results to APOL1 positive participants.
|
Delayed Return of Results (Modified Intent to Treat, mITT)
n=454 Participants
Delayed return of results to APOL1 positive participants after the completion of the 6 month final study visit.
|
|---|---|---|
|
Number of Participants With Documented Order of Microalbuminuria/Proteinuria Tests
|
302 Participants
|
264 Participants
|
SECONDARY outcome
Timeframe: From baseline to 6 month study visitPopulation: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).
Outcome measures
| Measure |
Immediate Return of Results (Modified Intent to Treat, mITT)
n=456 Participants
Immediate return of results to APOL1 positive participants.
|
Delayed Return of Results (Modified Intent to Treat, mITT)
n=441 Participants
Delayed return of results to APOL1 positive participants after the completion of the 6 month final study visit.
|
|---|---|---|
|
Number of Participants With a Change in Documented Diagnosis for Stage 3 CKD and Above
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From baseline to 6 month study visitPopulation: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).
Outcome measures
| Measure |
Immediate Return of Results (Modified Intent to Treat, mITT)
n=456 Participants
Immediate return of results to APOL1 positive participants.
|
Delayed Return of Results (Modified Intent to Treat, mITT)
n=441 Participants
Delayed return of results to APOL1 positive participants after the completion of the 6 month final study visit.
|
|---|---|---|
|
Number of Participants With Documented Diagnosis of CKD Stage 3 and Above
|
83 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: From baseline to 6 month study visitPopulation: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).
Outcome measures
| Measure |
Immediate Return of Results (Modified Intent to Treat, mITT)
n=456 Participants
Immediate return of results to APOL1 positive participants.
|
Delayed Return of Results (Modified Intent to Treat, mITT)
n=441 Participants
Delayed return of results to APOL1 positive participants after the completion of the 6 month final study visit.
|
|---|---|---|
|
Number of Participants With a Change in Documented Diagnosis for Any Stage CKD
|
31 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From baseline to 6 month study visitPopulation: Modified Intent To Treat (mITT) population, consisting of ITT participants with APOL1 positive phenotype (APOL1-HR).
Outcome measures
| Measure |
Immediate Return of Results (Modified Intent to Treat, mITT)
n=456 Participants
Immediate return of results to APOL1 positive participants.
|
Delayed Return of Results (Modified Intent to Treat, mITT)
n=441 Participants
Delayed return of results to APOL1 positive participants after the completion of the 6 month final study visit.
|
|---|---|---|
|
Number of Participants With Documented Diagnosis of All Stages of CKD
|
140 Participants
|
138 Participants
|
Adverse Events
Immediate Return of Results (Intent to Treat, ITT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 13 deaths
Delayed Return of Results (Intent to Treat, ITT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place