APOL1 Genotyping for Kidney Disease
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Genotyping
Participants submit a blood specimen for APOL1 Genotyping CTA to identify high-risk genotypes
Follow-up
Participants are monitored for safety and effectiveness after genotyping
Treatment Details
Interventions
- Synthetic Antisense Oligonucleotide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Almac Diagnostic Services LLC
Lead Sponsor