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APOL1 Genotyping CTA Clinical Performance Study

Almac Diagnostic Services LLC · NCT06839833

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
2000
US sites recruiting
1
Study start
March 6, 2025
Record last updated
July 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: APOL1 Genotyping

Conditions: APOL1-mediated Kidney Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Almac Diagnostic Services LLC

    Durham, NC 27704

    Site contact: Caoifa Dougan · 00442838337575 · ALDRegulatoryTeam@almacgroup.com

Study contacts (from the official record)

  • Caoifa Dougan · 00442838337575 · ALDRegulatoryTeam@almacgroup.com
  • Stewart McWilliams · 00442838337575 · ALDRegulatoryTeam@almacgroup.com
All healthy volunteers studies in North Carolina →
APOL1 Genotyping CTA Clinical Performance Study (NCT06839833) | Bored Studies