APOL1-mediated Kidney Disease
Conditions
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).
Interventions
DIAGNOSTIC_TESTAPOL1 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).
Sponsors
Almac Diagnostic Services LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
Almac Diagnostic Services receives de-identified specimens only for inclusion in the clinical performance study. The clinical trial protocol describes the blinding and un-blinding procedures for the clinical trial and this responsibility lies with the pharmaceutical clinical trial sponsor.
Intervention model description
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). I.e. The APOL1 Genotyping CTA being used interventionally as it is determining eligibility onto a trial, however not used to determine stratification into clinical trial cohorts.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of APOL1 genotype result within the study population (G1/G2/G0), for participants' specimens tested using the APOL1 Genotyping CTA | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet device turn-around time (TAT) | 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 |
| Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet laboratory TAT | 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 |
| Percentage of specimens submitted for APOL1 Genotyping CTA testing for which the device 'test was not ordered accurately (TNOA) | 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 |
| Percentage 'Specimens Not Accepted (SNA)' by the clinical laboratory(ies) for APOL1 Genotyping CTA testing | 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 |
| Percentage of Quality Control Failures | 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 |
| Percentage of corrected reports | 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 |
| Percentage of updated reports | 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 |
| Percentage homozygous or compound heterozygous for APOL1 high risk genotypes within the study population | Through study completion, approximately 1 year | To determine the expected homozygous/ compound heterozygous APOL1 high risk genotype prevalence |
Countries
United States
Contacts
CONTACTCaoifa Dougan
CONTACTStewart McWilliams
PRINCIPAL_INVESTIGATORRichard Kennedy, MD PhD FRCP
Almac Diagnostic Services Ltd
Outcome results
None listed