APOL1-mediated Kidney DiseaseNCT06839833
APOL1 Genotyping CTA Clinical Performance Study
A study testing APOL1 Genotyping in people with APOL1-mediated Kidney Disease, run by Almac Diagnostic Services LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- APOL1-mediated Kidney Disease
- What is being tested?
- APOL1 Genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Almac Diagnostic Services LLC
Durham, North Carolina, 27704
Caoifa Dougan, 00442838337575, ALDRegulatoryTeam@almacgroup.com
Richard Kennedy, MD PhD FRCP
About this study
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
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).
- Conditions
- APOL1-mediated Kidney Disease
- Being tested
- APOL1 Genotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOL1 GenotypingDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| APOL1 Genotyping | Other | 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). Receives: Diagnostic Test: APOL1 Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of APOL1 genotype result within the study population (G1/G2/G0), for participants' specimens tested using the APOL1 Genotyping CTA
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
Measured: Through study completion, approximately 1 year
Secondary outcomes (8)
Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet device turn-around time (TAT)
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Measured: Through study completion, approximately 1 year
Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet laboratory TAT
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Measured: 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)
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Measured: Through study completion, approximately 1 year
Percentage 'Specimens Not Accepted (SNA)' by the clinical laboratory(ies) for APOL1 Genotyping CTA testing
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Measured: Through study completion, approximately 1 year
Percentage of Quality Control Failures
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Measured: Through study completion, approximately 1 year
Percentage of corrected reports
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Measured: Through study completion, approximately 1 year
Percentage of updated reports
To demonstrate with objective evidence how the APOL1 Genotyping CTA will be expected to perform in routine clinical practice
Measured: Through study completion, approximately 1 year
Percentage homozygous or compound heterozygous for APOL1 high risk genotypes within the study population
To determine the expected homozygous/ compound heterozygous APOL1 high risk genotype prevalence
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start6 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for APOL1-mediated Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almac Diagnostic Services LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kennedy, MD PhD FRCP, Principal investigator, Almac Diagnostic Services Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839833
- Sponsor's protocol ID
- SP2024001
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD, inclusive of the APOL1 Genotyping Clinical Trial Assay result
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06839833
- Acronym / sponsor ID
- SP2024001
- Conditions
- APOL1-mediated Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Almac Diagnostic Services LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| APOL1 Genotyping | Other | Diagnostic Test: APOL1 GenotypingAll 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APOL1 GenotypingThe 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 |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. All IPD, inclusive of the APOL1 Genotyping Clinical Trial Assay result
Related trials for APOL1-mediated Kidney Disease
Active, not recruitingPhase 2
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APOL1-Mediated Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Kennedy, MD PhD FRCP principal investigator
Almac Diagnostic Services Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APOL1 Genotyping in people with APOL1-mediated Kidney Disease, run by Almac Diagnostic Services LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caoifa Dougan (00442838337575, ALDRegulatoryTeam@almacgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.