Actively Recruiting
APOL1 Genotyping CTA Clinical Performance Study
Led by Almac Diagnostic Services LLC · Updated on 2025-03-11
1000
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Clinical Performance Study SP2024001, is a prospective, interventional study to assess the clinical performance of the APOL1 Genotyping Clinical Trial Assay (CTA) in the intended use population and environment. The study will use the APOL1 Genotyping CTA to test deoxyribonucleic acid (DNA) extracted from blood specimens to identify individuals who are homozygous or compound heterozygous for apolipoprotein L1 (APOL1) high-risk genotypes (G1 and G2).The individuals who are identified as being homozygous or compound heterozygous for the APOL1 high-risk genotypes are candidates for enrolment onto an pharmaceutical company-sponsored, Phase 2b clinical trial which is investigating the safety and efficacy of a synthetic antisense oligonucleotide (ASO) for the treatment of APOL1-mediated kidney disease (AMKD).
CONDITIONS
Official Title
APOL1 Genotyping CTA Clinical Performance Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Identified by physician as a potential candidate for the pharmaceutical company-sponsored clinical trial based on inclusion criteria
- Agreed to and signed the clinical trial Informed Consent Form including risks related to 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 participant specimens must meet predetermined specifications for acceptance, including undamaged, appropriate volume, type, and disease indication
You will not qualify if you...
- Excluded by physician as a potential candidate for the pharmaceutical company-sponsored clinical trial based on exclusion criteria assessed at screening visit 1
- Has not agreed to or signed the Clinical Trial Informed Consent Form
- Specimen sent to the device test site without a complete Test Request Form
- Specimen did not meet predetermined specifications for acceptance for testing by the device test site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
R
Ruth A Scott, BSc (Hons)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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