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APOL1 Genotyping CTA Clinical Performance Study
Sponsor: Almac Diagnostic Services LLC
Summary
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).
Official title: A Prospective, Interventional Study to Assess the Clinical Performance of the APOL1 Genotyping Clinical Trial Assay in the Intended Use Population and Environment
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-03-06
Completion Date
2026-03
Last Updated
2025-03-11
Healthy Volunteers
Yes
Conditions
Interventions
APOL1 Genotyping
The APOL1 Genotyping CTA will 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).
Locations (1)
Almac Diagnostic Services LLC
Durham, North Carolina, United States