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New treatment option for Focal Segmental Glomerulosclerosis
Official title A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
ClinicalTrials.gov ID: NCT07268638
What this study is testing
What is Praliciguat?
Praliciguat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for focal segmental glomerulosclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS...
You likely can't join if
- Collapsing FSGS in the kidney biopsy report.
- Sickle cell disease.
- HbA1c \>8%.
- Uncontrolled hypertension (≥160/100 millimeters of mercury).
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
- Los Angeles, California, United States
- San Dimas, California, United States
- Arvada, Colorado, United States
- Boca Raton, Florida, United States
- Coral Springs, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Lawrenceville, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Livonia, Michigan, United States
- Pontiac, Michigan, United States
- New Bern, North Carolina, United States
- Cleveland, Ohio, United States
- Bridgeville, Pennsylvania, United States
- Butler, Pennsylvania, United States
- Goose Creek, South Carolina, United States
- Chattanooga, Tennessee, United States
- Arlington, Texas, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States; Los Angeles, California, United States; San Dimas, California, United States; Arvada, Colorado, United States; Boca Raton, Florida, United States; Coral Springs, Florida, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.