Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Praliciguat (Part A) for Focal Segmental Glomerulosclerosis

This is a Phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter study designed to measure the how well it works and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). you would be randomly assigned 1:1 to receive praliciguat or dummy treatment (placebo) for initial 24 week treatment period.

Official registry: https://clinicaltrials.gov/study/NCT07268638 · Akebia Therapeutics · enrollment listed as 60

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Praliciguat (Part A), Placebo (Part A), or Praliciguat (Part B). The registry lists allocation as randomized. This is a Phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter study designed to measure the how well it works and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS).

They plan to enroll about 60 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Praliciguat in Patients With Biopsy-Confirmed Focal Segmental Glomerulosclerosis

Interventions: Praliciguat (Part A), Placebo (Part A), Praliciguat (Part B)

Primary outcome (registry wording): Change from Baseline in urine protein-to-creatinine ratio (UPCR) (Part A)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • UPCR ≥1 (g/g) during screening
  • Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • 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

Public study contact (from the registry)

Akebia Therapeutics

16178446128

trials@akebia.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

32 listed

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FAQ about this NCT record

Is NCT07268638 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07268638?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07268638?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary