NCT06839833 APOL1 Genotyping CTA Clinical Performance Study
| NCT ID | NCT06839833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Almac Diagnostic Services LLC |
| Condition | APOL1-mediated Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-03-06 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Richard Kennedy, MD PhD FRCP
PRINCIPAL INVESTIGATOR
Almac Diagnostic Services Ltd
Frequently Asked Questions
Who can join the NCT06839833 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying APOL1-mediated Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839833 currently recruiting?
Yes, NCT06839833 is actively recruiting participants. Contact the research team at ALDRegulatoryTeam@almacgroup.com for enrollment information.
Where is the NCT06839833 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06839833 clinical trial?
NCT06839833 is sponsored by Almac Diagnostic Services LLC. The principal investigator is Richard Kennedy, MD PhD FRCP at Almac Diagnostic Services Ltd. The trial plans to enroll 1,000 participants.
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