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

NCT07268638 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-23

No results posted yet for this study

Summary

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 extension for an additional 24 weeks.

Conditions

Interventions

DRUG

Praliciguat

Oral Tablet

OTHER

Placebo

Oral Tablet

Sponsors & Collaborators

  • Akebia Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2027-06-30
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268638 on ClinicalTrials.gov