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

NCT ID: NCT07268638

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Focal Segmental Glomerulosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Praliciguat

Praliciguat will be administered daily with dose escalation to a target dose during a 24-week double-blind period, followed by a 24-week open-label treatment period.

Group Type EXPERIMENTAL

Praliciguat

Intervention Type DRUG

Oral Tablet

Placebo

Matching placebo will be administered daily for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral Tablet

Interventions

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Praliciguat

Oral Tablet

Intervention Type DRUG

Placebo

Oral Tablet

Intervention Type OTHER

Eligibility Criteria

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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 within 3 years of screening consistent with FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.

Exclusion Criteria

1. Collapsing FSGS in the kidney biopsy report.
2. Sickle cell disease.
3. HbA1c \>8% or non-fasting blood glucose \>180 milligram/decilitre.
4. Uncontrolled hypertension (≥160/100 millimeters of mercury)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akebia Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigator Site # 1

Lawrenceville, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Akebia Therapeutics

Role: CONTACT

[email protected]
16178446128

Other Identifiers

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AKB-1973-CI-0001

Identifier Type: -

Identifier Source: org_study_id