Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04191824
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2019-12-05
Brief Title:
Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUARDD-US
Brief Summary:
The primary aim is to determine the effect of participant and provider knowledge of a positive APOL1 status and accompanying guideline based clinical decision support CDS on blood pressure management on change in systolic blood pressure SBP from baseline to 3 months after randomization among the APOL1 positive participants Secondary aims are to
1 Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of documented CKD diagnosis
2 Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of receiving a urine microalbumincreatinine testing and ACE-IARB prescription based on results of the urine microalbumin level
3 Explore cost effectiveness mediators moderators psychobehavioral impact of results disclosure on participants and effects of participant and provider knowledge of APOL1 status on provider treatment recommendations
PGx Substudy
In addition GUARDD-US will include a substudy to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP from baseline to 3 months in APOL1 negative individuals
Approximately 6750 participants of African ancestry age 18-70 with hypertension that 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
Population for Main Study
Participants from Randomized Population above who test positive for APOL1
Population for PGx Substudy
Participants from Randomized Population above randomized to Intervention and who test negative for APOL1 Only participants from PGx substudy participating sites are included in this population
Main Study Analyses
To determine the effect of participant and provider knowledge of a positive APOL1 status on SBP we will compare the change in SBP from baseline to 3 months of the Intervention - APOL1 positive group to the change in SBP from baseline to 3 months of the Control - APOL1 positive group using a two sided t-test as appropriate with an overall two-sided type I error of 005
The effect of knowledge of a positive APOL1 status on all secondary endpoints will be compared between Intervention - APOL1 positives to Control - APOL1 positives with the proportion difference test
Additional analyses will include analysis of time trends in SBP subset analyses and exploratory analyses of cost effectiveness mediators moderators psychobehavioral impact of results disclosure on participants and effects of knowledge of APOL1 status on provider treatment recommendations
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
1 Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of documented CKD diagnosis
2 Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of receiving a urine microalbumincreatinine testing and ACE-IARB prescription based on results of the urine microalbumin level
3 Explore cost effectiveness mediators moderators psychobehavioral impact of results disclosure on participants and effects of participant and provider knowledge of APOL1 status on provider treatment recommendations
PGx Substudy
In addition GUARDD-US will include a substudy to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP from baseline to 3 months in APOL1 negative individuals
Approximately 6750 participants of African ancestry age 18-70 with hypertension that 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
Population for Main Study
Participants from Randomized Population above who test positive for APOL1
Population for PGx Substudy
Participants from Randomized Population above randomized to Intervention and who test negative for APOL1 Only participants from PGx substudy participating sites are included in this population
Main Study Analyses
To determine the effect of participant and provider knowledge of a positive APOL1 status on SBP we will compare the change in SBP from baseline to 3 months of the Intervention - APOL1 positive group to the change in SBP from baseline to 3 months of the Control - APOL1 positive group using a two sided t-test as appropriate with an overall two-sided type I error of 005
The effect of knowledge of a positive APOL1 status on all secondary endpoints will be compared between Intervention - APOL1 positives to Control - APOL1 positives with the proportion difference test
Additional analyses will include analysis of time trends in SBP subset analyses and exploratory analyses of cost effectiveness mediators moderators psychobehavioral impact of results disclosure on participants and effects of knowledge of APOL1 status on provider treatment recommendations
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None