← Back to Search

Genetic Testing for APOL1 Status in Kidney Disease (GUARDD-US Trial)

N/A

Waitlist Available

Led By Hrishikesh Chakraborty

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have diagnosis of hypertension

CKD is defined by either: 1) ICD10 codes (i.e., N18.x; E08.22; E09.22; E10.22; E11.22;E13.22 (exclude Z94.0; N18.6; Z99.2)) OR 15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

GUARDD-US Trial Summary

This trial is designed to see if knowing your APOL1 status and having clinical decision support based on that information can help manage blood pressure better. There are two groups, those that know their APOL1 status and those that don't, and the study will compare changes in blood pressure between the two groups. There is also a substudy looking at how well different blood pressure medications work in people with different APOL1 status.

Who is the study for?

This trial is for English-speaking African ancestry individuals aged 18-70 with hypertension, and either no diabetes/CKD or CKD alone. They must have visited a participating primary care site in the past year and plan to stay local for at least 6 months.Check my eligibility

What is being tested?

The study tests how knowing one's APOL1 genetic status and receiving guideline-based support affects blood pressure management. It also examines if this knowledge impacts CKD diagnosis, urine testing, medication prescription, treatment recommendations, and cost-effectiveness.See study design

What are the potential side effects?

Since the intervention involves genetic testing and clinical decision support rather than drugs or invasive procedures, typical medical side effects are not expected. However, there may be psychological or behavioral responses to learning one's genetic risk.

GUARDD-US Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with high blood pressure.

Select...

I have chronic kidney disease, confirmed by specific codes or tests showing my kidney function.

Select...

I am between 18 and 70 years old.

Select...

I have diabetes, confirmed by tests or diagnosis codes.

GUARDD-US Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in systolic blood pressure from baseline to 3 months

Secondary outcome measures

Appropriate diagnosis of CKD stage 3 and above

Appropriate diagnosis of all stage CKD

Appropriate order of microalbuminuria/proteinuria tests

+3 more

GUARDD-US Trial Design

2Treatment groups

Active Control

Group I: Immediate Return of ResultsActive Control1 Intervention

Immediate return of results to inform participant of APOL1 status (either positive or negative).

Group II: Delayed Return of ResultsActive Control1 Intervention

Delayed return of results of APOL1 status (either positive or negative) after the completion of the 6 month final study visit.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,413,752 Total Patients Enrolled

Hrishikesh ChakrabortyPrincipal InvestigatorDuke University

4 Previous Clinical Trials

8,222 Total Patients Enrolled

Media Library

Immediate Return of Results Clinical Trial Eligibility Overview. Trial Name: NCT04191824 — N/A

Kidney Disease Research Study Groups: Immediate Return of Results, Delayed Return of Results

Kidney Disease Clinical Trial 2023: Immediate Return of Results Highlights & Side Effects. Trial Name: NCT04191824 — N/A

Immediate Return of Results 2023 Treatment Timeline for Medical Study. Trial Name: NCT04191824 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can be considered eligible to participate in this trial?

"This trial is searching for 6650 individuals who possess kidney diseases and are aged between 18 to 70. Those enrolled must meet the following criteria: demonstrate African ancestry, be a native English speaker, present with hypertension via ICD10 codes or active antihypertensive medication; have systolic blood pressure of 140 mm Hg or higher within two out of three last recorded values in an EHR; list hypertension as an issue on their medical record problem list (diabetics included if they also have CKD); contain eGFR from 15-60 ml/min over at least 2 time periods ≥3 months; visited a participating primary"

Answered by AI

Are any elderly participants being included in this research endeavor?

"This clinical trial has an eligibility requirement of 18 years old as the minimum age, and 70 years as the maximum."

Answered by AI

Are any more participants needed for this research investigation?

"Affirmative. Clinicaltrials.gov illustrates that this medical trial, which was initially advertised on July 6th 2020, is still recruiting participants. Approximately 6650 individuals need to be enrolled from 11 distinct centres."

Answered by AI

How widespread is the trial's implementation at present?

"Currently, 11 sites are open and recruiting patients for the clinical trial. These include University of Florida (with two locations in Gainesville and Jacksonville), Icahn School of Medicine at Mount Sinai in New york as well as Baylor Research Institute in Dallas. There are 8 other operating medical centres associated with this study."

Answered by AI

What is the upper limit of individuals involved in this investigation?

"This clinical trial requires 6650 participants that satisfy the predetermined eligibility criteria. The study is available at various locations, such as University of Florida (Gainesville and Jacksonville) in Gainesville, FL and Icahn School of Medicine at Mount Sinai in NYC."

Answered by AI