An interventional study of APOL1 Genotyping in APOL1-mediated Kidney Disease, sponsored by Almac Diagnostic Services LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Almac Diagnostic Services LLC · Not applicable, Interventional, and Screening
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).
This is the only study on the registry with Almac Diagnostic Services LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All study participants will submit a blood specimen for APOL1 Genotyping CTA screening. 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).
Diagnostic Test: 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).
Assessment of APOL1 genotype result within the study population (G1/G2/G0), for participants' specimens tested using the APOL1 Genotyping CTA
To utilize the APOL1 Genotyping CTA as a screening test to identify participants homozygous or compound heterozygous for high risk APOL1 genotypes (G1/G2) for inclusion in a Ph 2b trial
Time frame: Through study completion, approximately 1 year
Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet device turn-around time (TAT)
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Time frame: Through study completion, approximately 1 year
Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet laboratory TAT
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Time frame: Through study completion, approximately 1 year
Percentage of specimens submitted for APOL1 Genotyping CTA testing for which the device 'test was not ordered accurately (TNOA)
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Time frame: Through study completion, approximately 1 year
Percentage 'Specimens Not Accepted (SNA)' by the clinical laboratory(ies) for APOL1 Genotyping CTA testing
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Time frame: Through study completion, approximately 1 year
Percentage of Quality Control Failures
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Time frame: Through study completion, approximately 1 year
Percentage of corrected reports
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Time frame: Through study completion, approximately 1 year
Percentage of updated reports
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Time frame: Through study completion, approximately 1 year
Percentage homozygous or compound heterozygous for APOL1 high risk genotypes within the study population
To determine the expected homozygous/ compound heterozygous APOL1 high risk genotype prevalence
Time frame: Through study completion, approximately 1 year
AE/SAE/ADE/UADE/SADE incident rate
Identification of AEs/ SAEs/ADE/UADE/SADE or complications associated with the APOL1 Genotyping CTA (participant and operator) inclusive of root cause identification (e.g., Device deficiency)
Time frame: Through study completion, approximately 1 year
Plan to share: Yes — All IPD, inclusive of the APOL1 Genotyping Clinical Trial Assay result
Supporting information: Study protocol, Csr, Analytic code
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