Trial Outcomes & Findings for Genetic Testing to Understand and Address Renal Disease Disparities (NCT NCT02234063)
NCT ID: NCT02234063
Last Updated: 2020-10-05
Results Overview
Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2052 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2020-10-05
Participant Flow
Patients were recruited from 15 academic, community and safety-net practices in New York City. 2052 participants were enrolled. however 2 participants were not randomized.
Participant milestones
| Measure |
Immediate Genetic Testing
Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment.
|
Control- Delayed Testing
Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
|---|---|---|
|
Overall Study
STARTED
|
1795
|
255
|
|
Overall Study
COMPLETED
|
1540
|
212
|
|
Overall Study
NOT COMPLETED
|
255
|
43
|
Reasons for withdrawal
| Measure |
Immediate Genetic Testing
Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment.
|
Control- Delayed Testing
Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
235
|
42
|
|
Overall Study
Withdrawal by Subject
|
20
|
1
|
Baseline Characteristics
Results available for those participants who chose to provide data for this measure.
Baseline characteristics by cohort
| Measure |
Control- Delayed Testing
n=255 Participants
Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
Immediate Genetic Testing
n=1795 Participants
Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment.
|
Total
n=2050 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 10 • n=255 Participants
|
53 years
STANDARD_DEVIATION 10 • n=1795 Participants
|
53 years
STANDARD_DEVIATION 10 • n=2050 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=255 Participants
|
1187 Participants
n=1795 Participants
|
1359 Participants
n=2050 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=255 Participants
|
608 Participants
n=1795 Participants
|
691 Participants
n=2050 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=255 Participants
|
0 Participants
n=1795 Participants
|
0 Participants
n=2050 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=255 Participants
|
0 Participants
n=1795 Participants
|
0 Participants
n=2050 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=255 Participants
|
0 Participants
n=1795 Participants
|
0 Participants
n=2050 Participants
|
|
Race (NIH/OMB)
Black or African American
|
255 Participants
n=255 Participants
|
1795 Participants
n=1795 Participants
|
2050 Participants
n=2050 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=255 Participants
|
0 Participants
n=1795 Participants
|
0 Participants
n=2050 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=255 Participants
|
0 Participants
n=1795 Participants
|
0 Participants
n=2050 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=255 Participants
|
0 Participants
n=1795 Participants
|
0 Participants
n=2050 Participants
|
|
Household income <$30,000/year
|
126 Participants
n=232 Participants • Results available for those participants who chose to provide data for this measure.
|
888 Participants
n=1588 Participants • Results available for those participants who chose to provide data for this measure.
|
1014 Participants
n=1820 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Education more than some college
|
162 Participants
n=255 Participants • Results available for those participants who chose to provide data for this measure.
|
1008 Participants
n=1791 Participants • Results available for those participants who chose to provide data for this measure.
|
1170 Participants
n=2046 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Married/Partner
|
72 Participants
n=253 Participants • Results available for those participants who chose to provide data for this measure.
|
540 Participants
n=1791 Participants • Results available for those participants who chose to provide data for this measure.
|
612 Participants
n=2044 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Type of Insurance
Private
|
118 Participants
n=255 Participants • Results available for those participants who chose to provide data for this measure.
|
745 Participants
n=1793 Participants • Results available for those participants who chose to provide data for this measure.
|
863 Participants
n=2048 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Type of Insurance
Medicaid
|
109 Participants
n=255 Participants • Results available for those participants who chose to provide data for this measure.
|
821 Participants
n=1795 Participants • Results available for those participants who chose to provide data for this measure.
|
930 Participants
n=2050 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Type of Insurance
Medicare
|
14 Participants
n=255 Participants • Results available for those participants who chose to provide data for this measure.
|
126 Participants
n=1795 Participants • Results available for those participants who chose to provide data for this measure.
|
140 Participants
n=2050 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Type of Insurance
Other
|
8 Participants
n=255 Participants • Results available for those participants who chose to provide data for this measure.
|
51 Participants
n=1795 Participants • Results available for those participants who chose to provide data for this measure.
|
59 Participants
n=2050 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Type of Insurance
None
|
6 Participants
n=255 Participants • Results available for those participants who chose to provide data for this measure.
|
50 Participants
n=1795 Participants • Results available for those participants who chose to provide data for this measure.
|
56 Participants
n=2050 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Charlson Comorbidity Index
0
|
141 Participants
n=255 Participants
|
924 Participants
n=1795 Participants
|
1065 Participants
n=2050 Participants
|
|
Charlson Comorbidity Index
1
|
61 Participants
n=255 Participants
|
481 Participants
n=1795 Participants
|
542 Participants
n=2050 Participants
|
|
Charlson Comorbidity Index
≥2
|
53 Participants
n=255 Participants
|
390 Participants
n=1795 Participants
|
443 Participants
n=2050 Participants
|
|
Baseline mean Systolic Blood Pressure
|
133.8 mmHg
STANDARD_DEVIATION 19.4 • n=254 Participants • Results available for those participants who chose to provide data for this measure.
|
134.2 mmHg
STANDARD_DEVIATION 19.6 • n=1795 Participants • Results available for those participants who chose to provide data for this measure.
|
134.1 mmHg
STANDARD_DEVIATION 19.5 • n=2049 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Body mass index
|
33.9 kg/m^2
STANDARD_DEVIATION 7.7 • n=254 Participants • Results available for those participants who chose to provide data for this measure.
|
32.4 kg/m^2
STANDARD_DEVIATION 7.7 • n=1795 Participants • Results available for those participants who chose to provide data for this measure.
|
32.5 kg/m^2
STANDARD_DEVIATION 7.6 • n=2049 Participants • Results available for those participants who chose to provide data for this measure.
|
|
Number of Participants with High health literacy
|
169 Participants
n=255 Participants • Results available for those participants who chose to provide data for this measure
|
1110 Participants
n=1793 Participants • Results available for those participants who chose to provide data for this measure
|
1279 Participants
n=2048 Participants • Results available for those participants who chose to provide data for this measure
|
|
Excellent/Very good self-reported Health
|
64 Participants
n=255 Participants
|
465 Participants
n=1795 Participants
|
529 Participants
n=2050 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsNumber of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
Outcome measures
| Measure |
Control- Delayed Testing
n=255 Participants
Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
Immediate Genetic Testing for APOL1 Negative
n=1561 Participants
Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
Immediate Genetic Testing for APOL1 Positive
n=234 Participants
Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
|---|---|---|---|
|
Number of Participants With Urine Protein Excretion
Kidney function urine test before randomization
|
33 Participants
|
278 Participants
|
39 Participants
|
|
Number of Participants With Urine Protein Excretion
Kidney function urine test after randomization
|
50 Participants
|
377 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Results available for those participants who returned for 3 month visit and had both timepoint data.
Change in systolic blood pressure at 3 months as compared to baseline
Outcome measures
| Measure |
Control- Delayed Testing
n=232 Participants
Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
Immediate Genetic Testing for APOL1 Negative
n=1468 Participants
Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
Immediate Genetic Testing for APOL1 Positive
n=218 Participants
Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure
|
-3 mmHg
Standard Deviation 18
|
-3 mmHg
Standard Deviation 16
|
-6 mmHg
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Survey only for participants who received genetic testing.
Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization
Outcome measures
| Measure |
Control- Delayed Testing
n=1468 Participants
Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
Immediate Genetic Testing for APOL1 Negative
n=218 Participants
Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
Immediate Genetic Testing for APOL1 Positive
Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
|---|---|---|---|
|
Number of Participants With Change in Medication Adherence
Changed how you take BP meds
|
146 Participants
|
53 Participants
|
—
|
|
Number of Participants With Change in Medication Adherence
Take BP meds more often
|
68 Participants
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Survey only for participants who received genetic testing.
Number of patients with changes in psychosocial behaviors 3 months after randomization
Outcome measures
| Measure |
Control- Delayed Testing
n=1468 Participants
Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
Immediate Genetic Testing for APOL1 Negative
n=218 Participants
Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
Immediate Genetic Testing for APOL1 Positive
Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
|---|---|---|---|
|
Number of Patients With Changes in Psychosocial Behaviors
|
547 Participants
|
129 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Survey only for participants who received genetic testing.
Patient attitude towards genetic testing 3 months after randomization
Outcome measures
| Measure |
Control- Delayed Testing
n=1468 Participants
Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|
Immediate Genetic Testing for APOL1 Negative
n=218 Participants
Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
Immediate Genetic Testing for APOL1 Positive
Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.
|
|---|---|---|---|
|
Number of Participants With Attitude Towards Genetic Testing
Had enough information on getting the test
|
1425 Participants
|
208 Participants
|
—
|
|
Number of Participants With Attitude Towards Genetic Testing
Information for test was easy to understand
|
1391 Participants
|
203 Participants
|
—
|
|
Number of Participants With Attitude Towards Genetic Testing
Would get tested again
|
1420 Participants
|
211 Participants
|
—
|
Adverse Events
Control- Delayed Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Genetic Testing for APOL1 Negative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Genetic Testing for APOL1 Positive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carol R. Horowitz
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9564
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place