N/A
N=2,050
Genetic Testing to Understand and Address Renal Disease Disparities
Hypertension · Chronic Kidney Disease · Genomics
Bottom Line
View on ClinicalTrials.gov: NCT02234063 ↗Enrolled (actual)
2,050
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Urine Protein Excretion — 33; 278; 39; 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immediate Genetic Testing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Urine Protein Excretion |
33; 278; 39; 50; 377; 68 | — |
| PRIMARY Change in Systolic Blood Pressure |
-3; -3; -6 | — |
| SECONDARY Number of Participants With Change in Medication Adherence |
146; 53; 68; 21 | — |
| SECONDARY Number of Patients With Changes in Psychosocial Behaviors |
547; 129 | — |
| SECONDARY Number of Participants With Attitude Towards Genetic Testing |
1425; 208; 1391; 203; 1420; 211 | — |
Summary
In this genomic medicine implementation pilot project, the investigators aim to conduct a randomized trial in a network of community health centers and primary care facilities to study processes, effects and challenges of incorporating information for apolipoprotein L1 (APOL1)-attributable genetic risk for end stage kidney disease in patients of African ancestry with hypertension .
Eligibility Criteria
Inclusion Criteria
- Ages18-65
- Self-identifies as Black/African American
- History of hypertension
- Patient at a participating site
Exclusion Criteria
- History of Chronic Kidney Disease
- History of Diabetes
- Pregnant
- Cognitively impaired/unable to provide consent
- Terminally ill
- Planning to leave area of study permanently during the one year study period
Data sourced from ClinicalTrials.gov (NCT02234063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.