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
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
More Related Trials
-
A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)
NCT01665391 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
NCT07220083 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
NCT03448692 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
NCT03703908 ·Status: TERMINATED ·Phase: PHASE2
-
A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147
NCT05955872 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of CCX140-B in Subjects With FSGS
NCT03536754 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)
NCT02000440 ·Status: COMPLETED ·Phase: PHASE2
-
Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)
NCT00193648 ·Status: COMPLETED ·Phase: PHASE1
-
Sirolimus for Focal Segmental Glomerulosclerosis
NCT00040508 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis
NCT04340362 ·Status: COMPLETED ·Phase: PHASE2
-
Permeability Factor in Focal Segmental Glomerulosclerosis
NCT00007475 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
NCT03763643 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS
NCT00464321 ·Status: COMPLETED ·Phase: PHASE1
-
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
NCT00956059 ·Status: UNKNOWN ·Phase: NA
-
Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
NCT03598036 ·Status: TERMINATED ·Phase: PHASE2
-
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
NCT00302536 ·Status: WITHDRAWN ·Phase: NA
-
Rituximab to Prevent Recurrence of Proteinuria
NCT01164098 ·Status: TERMINATED ·Phase: PHASE3
-
Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT)
NCT00135811 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
NCT04387448 ·Status: TERMINATED ·Phase: PHASE2
-
Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects
NCT02585804 ·Status: COMPLETED ·Phase: PHASE4
-
Cardiomyopathy in Steroid-resistant Nephrotic Syndrome: Impact of Focal Segmental Glomerulosclerosis
NCT00883636 ·Status: TERMINATED
-
Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)
NCT00782561 ·Status: TERMINATED ·Phase: PHASE1
-
Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment
NCT06529796 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases
NCT04950114 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
NCT05183646 ·Status: RECRUITING ·Phase: PHASE3