Actively Recruiting
A Prospective, Interventional Study to Assess the Clinical Performance of the APOL1 Genotyping Clinical Trial Assay in the Intended Use Population and Environment
Led by Almac Diagnostic Services LLC · Updated on 2025-03-11
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance of the APOL1 Genotyping Clinical Trial Assay (CTA) in individuals to identify those who carry high-risk APOL1 genotypes (G1 and G2). This prospective, interventional study focuses on testing DNA extracted from blood specimens to find people who are homozygous or compound heterozygous for these genotypes. Those identified may be eligible for a pharmaceutical company-sponsored Phase 2b trial investigating a synthetic antisense oligonucleotide (ASO) treatment for APOL1-mediated kidney disease (AMKD). All participants will provide a blood sample for APOL1 genotyping using the CTA. This test detects whether a person has the high-risk APOL1 genotypes. Individuals found to carry these genotypes are candidates for enrollment in the related Phase 2b clinical trial assessing the ASO therapy's safety and efficacy. The study involves specimen collection, testing, and data recording within the intended use population and environment. Participants will be involved in submitting a blood specimen accompanied by proper documentation for testing. The study team will assess test results, including genotype identification and various quality measures like turnaround times and specimen acceptance rates. The primary outcome is the assessment of APOL1 genotype results over about one year. Secondary outcomes include measures of test performance and reporting accuracy. Participant involvement includes providing consent and meeting specimen requirements to support testing and analysis.
CONDITIONS
Brief Title
APOL1 Genotyping CTA Clinical Performance Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be identified by their physician as potential candidates for the pharmaceutical company-sponsored clinical trial based on its inclusion criteria.
- Participants must have agreed to and signed the clinical trial Informed Consent Form, including risks related to the APOL1 Genotyping CTA.
- Participant's specimen must be sent to the device test site with a complete Test Request Form signed by clinical trial personnel.
- All specimens must meet specifications such as being undamaged, appropriate volume and type, and proper disease indication for testing acceptance.
You will not qualify if you...
- Participants excluded by their physician based on the pharmaceutical company-sponsored clinical trial exclusion criteria at screening visit 1.
- Participants who have not agreed to or signed the Clinical Trial Informed Consent Form.
- Specimens sent without a complete Test Request Form.
- Specimens that do not meet predetermined specifications for testing acceptance at the device test site.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants provide a blood specimen for APOL1 Genotyping CTA screening to identify high-risk genotypes. Participants are observed as the test results are processed and assessed.
Specimen submission with follow-up as needed
Trial Site Locations
Total: 1 location
1
Almac Diagnostic Services LLC
Durham, North Carolina, United States, 27704
Actively Recruiting
Research Team
C
Charlene Robb, MPharm PhD
R
Ruth A Scott, BSc (Hons)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here