Praliciguat treatment for adults with focal segmental glomerulosclerosis (FSGS)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, double-blind, placebo-controlled multicenter study will assign adults with biopsy-confirmed FSGS 1:1 to receive praliciguat or placebo for a 24-week blinded period. Eligible participants must have UPCR ≥1 g/g, eGFR ≥25 mL/min/1.73 m2, and be on maximally tolerated ACEi or ARB therapy. After 24 weeks, all participants enter a 24-week open-label extension where everyone receives praliciguat. Key exclusions include collapsing FSGS, sickle cell disease, poor glycemic control (HbA1c >8% or non-fasting glucose >180 mg/dL), and uncontrolled hypertension.

Why it matters

Who can join: the full rules

Inclusion Criteria (Part A):

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 (Part A):

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

Inclusion Criteria (Part B):

1\. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.

Where it's running

• Investigator Site #2
  Chula Vista, California, United States Recruiting
• Investigator Site #28
  Garden Grove, California, United States Recruiting
• Investigator Site #14
  Los Angeles, California, United States Recruiting
• Investigator Site #12
  San Dimas, California, United States Recruiting
• Investigator Site #13
  Arvada, Colorado, United States Recruiting
• Investigator Site #17
  Boca Raton, Florida, United States Recruiting

Study contacts

• Study coordinator: Akebia Therapeutics
• Email: trials@akebia.com
• Phone: 16178446128

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BI 764198 for adults and adolescents with focal segmental glomerulosclerosis (FSGS).

  This study will test BI 764198 tablets taken once daily for up to two years in adults and adolescents with FSGS to see if it lowers urine protein and preserves kidney function.

  Recruiting at 253 sites Phase 3 Boehringer Ingelheim · Alabaster, Alabama and 314 other locations · NCT07220083

• Testing ManNAc for treating kidney disease FSGS

  This study is testing if a new oral treatment called ManNAc can help adults with kidney disease FSGS by reducing protein levels in their urine and checking how safe it is over 12 weeks.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06664814

• Evaluating treatments for kidney diseases in young to middle-aged adults

  This study is testing three different treatments for kidney diseases in young to middle-aged adults to see if they can reduce protein levels in urine and help with symptoms over 24 weeks.

  Recruiting at 78 sites Phase 2 Sanofi · Birmingham, Alabama and 78 other locations · NCT06500702

• Registry and biobank for resistant nephrotic syndrome treatment responses

  This study is collecting information from patients with resistant nephrotic syndrome to see how different treatments work and to help find better options for the future.

  Recruiting Medical University of Vienna · Vienna · NCT06162546

• Using Metformin to Improve Kidney Health in FSGS

  This study is testing if taking extended-release Metformin along with regular treatment can help improve kidney health in people with Focal Segmental Glomerulosclerosis (FSGS).

  Recruiting at 2 sites Phase 1/2 Yale University · New Haven, Connecticut and 1 other locations · NCT06090227

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.