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A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)

RecruitingPhase 2Ages 18 Years - anyAllAkebia Therapeutics
NCT07268638 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label period for an additional 24 weeks. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.

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📋 Eligibility rules (as published)
Inclusion Criteria (Part A): 1. UPCR ≥1 (g/g) during screening. 2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent. 3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 4. Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS. Exclusion Criteria (Part A): 1. Collapsing FSGS in the kidney biopsy report. 2. Sickle cell disease. 3. HbA1c \>8%. 4. Uncontrolled hypertension (≥160/100 millimeters of mercury). Inclusion Criteria (Part B): 1\. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
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What it tests

  • Praliciguat (Part A)
  • Placebo (Part A)
  • Praliciguat (Part B)
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Where

30 sites
Investigator Site #2
Chula Vista, United States
Investigator Site #28
Garden Grove, United States
Investigator Site #14
Los Angeles, United States
Investigator Site #12
San Dimas, United States
Investigator Site #13
Arvada, United States
Investigator Site #17
Boca Raton, United States
Investigator Site #6
Coral Springs, United States
Investigator Site #25
Hialeah, United States

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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