Trial Outcomes & Findings for Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD (NCT NCT05734989)
NCT ID: NCT05734989
Last Updated: 2026-04-24
Results Overview
Recruitment status
COMPLETED
Target enrollment
248 participants
Primary outcome timeframe
up to 3 months after screening
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
Hispanic/Latinx Patients at Risk for CKD
Adult Hispanic individuals in the Durham community screened for CKD
Urine protein/glucose screening, blood pressure measurements, and BMI measures will be conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk will be referred to PCP for follow up/treatment.
|
Screening/Treatment Group
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for one or more of the following screens/interventions: 1) Annual urine albumin/creatinine screen; 2) Initiation of renin-angiotensin-aldosterone system (RAAS) inhibitor; 3) Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitor, and/or glucagon-like peptide-1 (GLP-1) receptor agonist (RA)
|
Optimal Care Group
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, not eligible for any of the screens/interventions
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
97
|
92
|
|
Overall Study
COMPLETED
|
31
|
97
|
92
|
|
Overall Study
NOT COMPLETED
|
28
|
0
|
0
|
Reasons for withdrawal
| Measure |
Hispanic/Latinx Patients at Risk for CKD
Adult Hispanic individuals in the Durham community screened for CKD
Urine protein/glucose screening, blood pressure measurements, and BMI measures will be conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk will be referred to PCP for follow up/treatment.
|
Screening/Treatment Group
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for one or more of the following screens/interventions: 1) Annual urine albumin/creatinine screen; 2) Initiation of renin-angiotensin-aldosterone system (RAAS) inhibitor; 3) Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitor, and/or glucagon-like peptide-1 (GLP-1) receptor agonist (RA)
|
Optimal Care Group
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, not eligible for any of the screens/interventions
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
28
|
0
|
0
|
Baseline Characteristics
Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD
Baseline characteristics by cohort
| Measure |
Hispanic/Latinx Patients at Risk for CKD
n=59 Participants
Adult Hispanic individuals in the Durham community screened for CKD
Urine protein/glucose screening, blood pressure measurements, and BMI measures will be conducted, in addition to obtaining information about family history of diabetes, to identify participants with or at risk for chronic kidney disease. Those identified as being at risk will be referred to PCP for follow up/treatment.
|
Screening/Treatment Group
n=97 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for one or more of the following screens/interventions: 1) Annual urine albumin/creatinine screen; 2) Initiation of renin-angiotensin-aldosterone system (RAAS) inhibitor; 3) Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitor, and/or glucagon-like peptide-1 (GLP-1) receptor agonist (RA)
|
Optimal Care Group
n=92 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, not eligible for any of the screens/interventions
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.61 years
STANDARD_DEVIATION 12.09 • n=2 Participants
|
63.5 years
STANDARD_DEVIATION 14.2 • n=1 Participants
|
62.8 years
STANDARD_DEVIATION 13.3 • n=3 Participants
|
57.8 years
STANDARD_DEVIATION 13.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=2 Participants
|
63 Participants
n=1 Participants
|
58 Participants
n=3 Participants
|
155 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=2 Participants
|
34 Participants
n=1 Participants
|
34 Participants
n=3 Participants
|
93 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=2 Participants
|
7 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
69 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=2 Participants
|
90 Participants
n=1 Participants
|
88 Participants
n=3 Participants
|
178 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
91 Participants
n=1 Participants
|
89 Participants
n=3 Participants
|
180 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
52 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
16 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=2 Participants
|
97 Participants
n=1 Participants
|
92 Participants
n=3 Participants
|
248 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: up to 3 months after screeningPopulation: Only relevant to the Hispanic/Latinx patients at risk for CKD group; 28 participants were lost to follow-up.
Outcome measures
| Measure |
Screening/Treatment Group
n=31 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for a RAASi (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) based on the most updated KDIGO and/or ADA guidelines, without any contraindications to treatment
|
Optimal Care Group
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, who are either 1) Already on a RAASi; 2) Not eligible for a RAASi based on the most updated KDIGO and/or ADA guidelines; or 3) Have a contraindication to treatment
|
|---|---|---|
|
Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: Within three months of T0 (primary care appointment)Population: Not relevant to the Hispanic/Latinx patients at risk for CKD group. Participants in the Screening/Treatment Group were only included if they had not already received a uACR.
Outcome measures
| Measure |
Screening/Treatment Group
n=68 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for a RAASi (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) based on the most updated KDIGO and/or ADA guidelines, without any contraindications to treatment
|
Optimal Care Group
n=92 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, who are either 1) Already on a RAASi; 2) Not eligible for a RAASi based on the most updated KDIGO and/or ADA guidelines; or 3) Have a contraindication to treatment
|
|---|---|---|
|
Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening
|
40 Participants
|
92 Participants
|
PRIMARY outcome
Timeframe: Within three months of T0 (primary care appointment)Population: Not relevant to the Hispanic/Latinx patients at risk for CKD group. Participants in the Screening/Treatment Group were only included if they had not already received a SGLT2i or GLP-1 RA. Participants in the Optimal Care Group were only included if deemed eligible to receive a SGLT2i or GLP-1 RA.
Outcome measures
| Measure |
Screening/Treatment Group
n=43 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for a RAASi (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) based on the most updated KDIGO and/or ADA guidelines, without any contraindications to treatment
|
Optimal Care Group
n=68 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, who are either 1) Already on a RAASi; 2) Not eligible for a RAASi based on the most updated KDIGO and/or ADA guidelines; or 3) Have a contraindication to treatment
|
|---|---|---|
|
Number of Participants Who Were Prescribed an SGLT2 Inhibitor (SGLT2i) and/or a GLP-1 Receptor Agonist (GLP-1 RA)
|
16 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: Within three months of T0 (primary care appointment)Population: Not relevant to the Hispanic/Latinx patients at risk for CKD group. Participants in the Screening/Treatment Group were only included if they had not already received a RAASi. Participants in the Optimal Care Group were only included if deemed eligible to receive a RAASi.
Outcome measures
| Measure |
Screening/Treatment Group
n=9 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, eligible for a RAASi (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) based on the most updated KDIGO and/or ADA guidelines, without any contraindications to treatment
|
Optimal Care Group
n=74 Participants
Adult Black or Hispanic Patients with T2D, seen in Duke Health primary care, who are either 1) Already on a RAASi; 2) Not eligible for a RAASi based on the most updated KDIGO and/or ADA guidelines; or 3) Have a contraindication to treatment
|
|---|---|---|
|
Number of Participants Who Were Prescribed a Renin-Angiotensin-Aldosterone System Inhibitor (RAASi)
|
2 Participants
|
74 Participants
|
Adverse Events
Hispanic/Latinx Patients at Risk for CKD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Screening/Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optimal Care Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place