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NCT Number: NCT06839833

APOL1 Genotyping CTA Clinical Performance Study

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).

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Key information

Conditions

APOL1-mediated Kidney Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Almac Diagnostic Services LLC

Durham, North Carolina, 27704, United States

Location status: Recruiting

Location contact

Caoifa Dougan

CONTACT

[email protected]

00442838337575

Richard Kennedy, MD PhD FRCP

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APOL1 Genotyping

Diagnostic Test

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).

Primary outcomes

  1. Assessment of APOL1 genotype result within the study population (G1/G2/G0), for participants' specimens tested using the APOL1 Genotyping CTA

    Time frame: Through study completion, approximately 1 year

    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

Secondary outcomes

  1. Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet device turn-around time (TAT)

    Time frame: Through study completion, approximately 1 year

    To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice

  2. Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet laboratory TAT

    Time frame: Through study completion, approximately 1 year

    To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice

  3. Percentage of specimens submitted for APOL1 Genotyping CTA testing for which the device 'test was not ordered accurately (TNOA)

    Time frame: Through study completion, approximately 1 year

    To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice

  4. Percentage 'Specimens Not Accepted (SNA)' by the clinical laboratory(ies) for APOL1 Genotyping CTA testing

    Time frame: Through study completion, approximately 1 year

    To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice

  5. Percentage of Quality Control Failures

    Time frame: Through study completion, approximately 1 year

    To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice

  6. Percentage of corrected reports

    Time frame: Through study completion, approximately 1 year

    To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice

  7. Percentage of updated reports

    Time frame: Through study completion, approximately 1 year

    To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice

  8. Percentage homozygous or compound heterozygous for APOL1 high risk genotypes within the study population

    Time frame: Through study completion, approximately 1 year

    To determine the expected homozygous/ compound heterozygous APOL1 high risk genotype prevalence

Other outcomes

  1. AE/SAE/ADE/UADE/SADE incident rate

    Time frame: Through study completion, approximately 1 year

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Caoifa Dougan

CONTACT

[email protected]

00442838337575

Stewart McWilliams

CONTACT

[email protected]

00442838337575

Sponsors and collaborators

Lead sponsor

Almac Diagnostic Services LLC

Industry

Registry information

Official study title

A Prospective, Interventional Study to Assess the Clinical Performance of the APOL1 Genotyping Clinical Trial Assay in the Intended Use Population and Environment

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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