Testing for APOL1 Genotypes in Kidney Disease Patients
A Prospective, Interventional Study to Assess the Clinical Performance of the APOL1 Genotyping Clinical Trial Assay in the Intended Use Population and Environment
This study is testing a new DNA test to see if it can identify people at high risk for kidney disease due to specific gene variations, so they can join a trial for a new treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Almac Diagnostic Services LLC Industry-sponsored |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06839833 on ClinicalTrials.gov |
What this trial studies
This clinical performance study aims to evaluate the effectiveness of the APOL1 Genotyping Clinical Trial Assay (CTA) in identifying individuals with high-risk APOL1 genotypes associated with kidney disease. Participants will have their DNA extracted from blood samples to determine if they are homozygous or compound heterozygous for the APOL1 high-risk variants. Those identified will be eligible for a subsequent Phase 2b clinical trial investigating a new treatment for APOL1-mediated kidney disease. The study is designed to ensure that the genotyping process meets specific performance criteria in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who are suspected of having APOL1-mediated kidney disease and meet the inclusion criteria for the subsequent clinical trial.
Not a fit: Patients who do not have APOL1 high-risk genotypes or do not meet the eligibility criteria for the pharmaceutical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients at risk for APOL1-mediated kidney disease and facilitate access to targeted therapies.
How similar studies have performed: While this approach is focused on genotyping for a specific condition, similar studies have shown promise in identifying genetic risk factors for various diseases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Almac Diagnostic Services LLC — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Richard Kennedy, MD PhD FRCP — Almac Diagnostic Services Ltd
- Study coordinator: Charlene Robb, MPharm PhD
- Email: ALDRegulatoryTeam@almacgroup.com
- Phone: 00442838337575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.