Clinical trial NCT06839833: APOL1 Genotyping CTA Clinical Performance Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: APOL1-mediated Kidney Disease
Lead sponsor: Almac Diagnostic Services LLC
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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). I.e. The APOL1 Genotyping CTA being used interventionally as it is determining eligibility onto a trial, however not used to determine stratification into clinical trial cohorts.
Primary purpose: SCREENING

Brief 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).


Eligibility criteria: Inclusion Criteria:

* Study participants must be identified as a potential candidate for the pharmaceutical company- sponsored clinical trial by their physician based on the clinical trial inclusion criteria.
* Study participant has agreed to and signed the clinical trial Informed Consent Form (inclusive of risks related to the APOL1 Genotyping CTA).
* The study participant's specimen must be distributed to the device test site accompanied by a complete Test Request Form signed by the appropriate clinical trial site personnel.
* All participant specimens must meet predetermined specifications (e.g., undamaged, appropriate volume, appropriate specimen type, appropriate disease indication) for acceptance for testing by the device test site in accordance with established procedures.

Exclusion Criteria:

* Study participants will be excluded as a potential candidate for the pharmaceutical company -sponsored clinical trial by their physician based on the clinical trial exclusion criteria as assessed at screening visit 1.
* The study participant has not agreed to and signed the (Clinical Trial) Informed Consent Form.
* The study participant's specimen is distributed to the device test site without a complete Test Request Form.
* The study participant's specimen did not meet predetermined specifications for acceptance for testing by the device test site in accordance with established procedures.

Primary outcomes:
measure: Assessment of APOL1 genotype result within the study population (G1/G2/G0), for participants' specimens tested using the APOL1 Genotyping CTA
timeFrame: Through study completion, approximately 1 year
Secondary outcomes:
measure: Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet device turn-around time (TAT)
timeFrame: Through study completion, approximately 1 year
measure: Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet laboratory TAT
timeFrame: Through study completion, approximately 1 year
measure: Percentage of specimens submitted for APOL1 Genotyping CTA testing for which the device 'test was not ordered accurately (TNOA)
timeFrame: Through study completion, approximately 1 year
measure: Percentage 'Specimens Not Accepted (SNA)' by the clinical laboratory(ies) for APOL1 Genotyping CTA testing
timeFrame: Through study completion, approximately 1 year
measure: Percentage of Quality Control Failures
timeFrame: Through study completion, approximately 1 year
measure: Percentage of corrected reports
timeFrame: Through study completion, approximately 1 year
measure: Percentage of updated reports
timeFrame: Through study completion, approximately 1 year
measure: Percentage homozygous or compound heterozygous for APOL1 high risk genotypes within the study population
timeFrame: Through study completion, approximately 1 year
Other outcomes:
measure: AE/SAE/ADE/UADE/SADE incident rate
timeFrame: Through study completion, approximately 1 year
Locations:
city: Durham
country: United States
facility: Almac Diagnostic Services LLC
state: North Carolina
Study officials:
affiliation: Almac Diagnostic Services Ltd
name: Richard Kennedy, MD PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References: