NCT07268638 · Akebia Therapeutics
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
What this study is about
This is a Phase 2, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, conducted at multiple hospitals study designed to evaluate the effectiveness and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- UPCR ≥1 (g/g) during screening.
- On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.
- Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- 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
- Collapsing FSGS in the kidney biopsy report.
- Sickle cell disease.
- HbA1c \>8% or non-fasting blood glucose \>180 milligram/decilitre.
- Uncontrolled hypertension (≥160/100 millimeters of mercury)
Where
- Chula Vista, California
- Los Angeles, California
- San Dimas, California
- Arvada, Colorado
- Coral Springs, Florida
- Miami, Florida
- Orlando, Florida
- Lawrenceville, Georgia
- Chicago, Illinois
- Louisville, Kentucky
- Pontiac, Michigan
- Chattanooga, Tennessee
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations