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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07268638

Enrollment

Registered

2025-12-08

Start date

2025-12-03

Completion date

2028-01-01

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Segmental Glomerulosclerosis

Keywords

Glomerular Disease, Chronic Kidney Disease, Proteinuria, Urine protein-to-creatinine ratio

Brief 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.

Interventions

DRUGPraliciguat

Oral Tablet

OTHERPlacebo

Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

1. Collapsing FSGS in the kidney biopsy report. 2. Sickle cell disease. 3. HbA1c \>8%. 4. Uncontrolled hypertension (≥160/100 millimeters of mercury).

Design outcomes

Primary

Measure	Time frame
Change from Baseline in urine protein-to-creatinine ratio (UPCR)	Baseline (Day 1) and up to Week 24

Secondary

Measure	Time frame	Description
Percentage of Participants with Partial Remission at Week 24	Up to Week 24	Partial remission is defined as 40% UPCR reduction and UPCR\<1.5 gram/gram (g/g).
Plasma concentrations of praliciguat	Week 24, Week 32, and Week 36	—

Countries

United States

Contacts

CONTACTAkebia Therapeutics

trials@akebia.com16178446128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026