1000 Participants Needed

APOL1 Genotyping for Kidney Disease

CR
RA
Overseen ByRuth A Scott, BSc (Hons)
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Almac Diagnostic Services LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Synthetic Antisense Oligonucleotide treatment safe for humans?

Research on a treatment called IONIS-APOL1Rx, a type of Synthetic Antisense Oligonucleotide, showed it was effective in mice for reducing kidney problems related to the APOL1 gene. However, there is no specific safety data available for humans yet, so more studies are needed to confirm its safety in people.12345

How does the drug Synthetic Antisense Oligonucleotide differ from other treatments for APOL1-related kidney disease?

This drug is unique because it targets the APOL1 gene directly, using antisense oligonucleotides (short DNA or RNA molecules) to reduce the production of harmful proteins linked to kidney disease, offering a personalized approach for those with specific genetic risk factors.23567

What is the purpose of this trial?

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).

Research Team

RK

Richard Kennedy, MD PhD FRCP

Principal Investigator

Almac Diagnostic Services Ltd

Eligibility Criteria

This trial is for individuals who may have a genetic risk for kidney disease. They will be tested to see if they carry certain high-risk genes (APOL1 G1 and G2) that could make them eligible for another study on a new treatment.

Inclusion Criteria

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
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
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Exclusion Criteria

The study participant's specimen is distributed to the device test site without a complete Test Request Form
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
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Genotyping

Participants submit a blood specimen for APOL1 Genotyping CTA to identify high-risk genotypes

Approximately 1 year
Ongoing monitoring

Follow-up

Participants are monitored for safety and effectiveness after genotyping

4 weeks

Treatment Details

Interventions

  • Synthetic Antisense Oligonucleotide
Trial Overview The trial is testing the accuracy of the APOL1 Genotyping Clinical Trial Assay, which uses blood samples to detect specific genetic markers associated with an increased risk of kidney disease.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: APOL1 GenotypingExperimental Treatment1 Intervention
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Almac Diagnostic Services LLC

Lead Sponsor

Trials
1
Recruited
1,000+

Findings from Research

Research indicates that the APOL1 gene is linked to chronic kidney disease (CKD), particularly in individuals of recent African ancestry, and understanding its mechanisms could enhance kidney transplant safety and donor allocation.
Local production of the APOL1 renal-risk variant in the kidneys plays a significant role in nephropathy development, but not all individuals with high-risk genotypes will experience CKD, suggesting that environmental factors may be more influential than genetic interactions in determining kidney health.
Mechanisms of Injury in APOL1-associated Kidney Disease.Ma, L., Divers, J., Freedman, BI.[2022]
A new mouse model expressing human APOL1 gene allows for better study of APOL1-associated kidney disease, particularly in understanding how the G1 variant contributes to renal issues when combined with inflammatory triggers like IFN-ฮณ.
The antisense oligonucleotide IONIS-APOL1Rx effectively reduced APOL1 expression and protected against kidney damage in APOL1 G1 mice, suggesting it could be a promising treatment for kidney diseases linked to APOL1 variants.
Antisense oligonucleotide treatment ameliorates IFN-ฮณ-induced proteinuria in APOL1-transgenic mice.Aghajan, M., Booten, SL., Althage, M., et al.[2020]
Not all individuals with the high-risk APOL1 genotype develop kidney disease, indicating that other factors may influence disease progression.
The study identifies several biomarkers associated with renal outcomes in high-risk APOL1 individuals, which could enhance risk assessment and understanding of APOL1 nephropathy mechanisms in precision medicine.
"Biomarking" the transition from genetic risk to kidney disease.Kruzel-Davila, E., Skorecki, K.[2022]

References

Mechanisms of Injury in APOL1-associated Kidney Disease. [2022]
Antisense oligonucleotide treatment ameliorates IFN-ฮณ-induced proteinuria in APOL1-transgenic mice. [2020]
"Biomarking" the transition from genetic risk to kidney disease. [2022]
Treatment potential in APOL1-associated nephropathy. [2023]
Apolipoprotein L1 Gene Effects on Kidney Transplantation. [2023]
APOL1 and kidney disease. [2022]
Rapid detection and quantification of apolipoprotein L1 genetic variants and total levels in plasma by ultra-performance liquid chromatography/tandem mass spectrometry. [2019]
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