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Recruiting NCT06839833

APOL1 Genotyping CTA Clinical Performance Study

No phase Interventional APOL1-mediated Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APOL1 Genotyping.
Who it may be relevant to
Registry conditions: APOL1-mediated Kidney Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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 kid

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet device turn-around time (TAT) [Time frame: 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]
  • 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]
  • Percentage 'Specimens Not Accepted (SNA)' by the clinical laboratory(ies) for APOL1 Genotyping CTA testing [Time frame: Through study completion, approximately 1 year]
  • Percentage of Quality Control Failures [Time frame: Through study completion, approximately 1 year]
  • Percentage of corrected reports [Time frame: Through study completion, approximately 1 year]
  • Percentage of updated reports [Time frame: 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Almac Diagnostic Services LLC — Durham

Identifiers

NCT: NCT06839833 · SP2024001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗