APOL1 Genotyping CTA Clinical Performance Study

March 6, 2025 updated by: Almac Diagnostic Services LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Recruiting
        • Almac Diagnostic Services LLC
        • Contact:
        • Contact:
          • Richard Kennedy, MD PhD FRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: APOL1 Genotyping
All study participants will submit a blood specimen for APOL1 Genotyping CTA screening. 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).
Diagnostic test: APOL1 Genotyping
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, approximately 1 year
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
Through study completion, approximately 1 year
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
Through study completion, approximately 1 year
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
Through study completion, approximately 1 year
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
Through study completion, approximately 1 year
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
Through study completion, approximately 1 year
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
Through study completion, approximately 1 year
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
Through study completion, approximately 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through study completion, approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almac Diagnostic Services LLC

Investigators

  • Principal Investigator: Richard Kennedy, MD PhD FRCP, Almac Diagnostic Services Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP2024001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD, inclusive of the APOL1 Genotyping Clinical Trial Assay result

IPD Sharing Time Frame

Start date March 2025 End date March 2027

IPD Sharing Access Criteria

The results of the APOL1 Genotyping CTA will be returned to the requesting clinical site (inclusive of clinical trial investigator) and the pharmaceutical clinical trial sponsor. The clinical trial investigator may return the result, if requested by the participant with appropriate genetic counselling. The device study will utilize remote electronic data capture systems to store and transfer data. Transfer of device data from Almac Diagnostic Services to the pharmaceutical clinical trial sponsor or other 3rd parties will be governed by agreed data transfer agreements and in line with local regulations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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