A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Purpose
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.
Condition
- Focal Segmental Glomerulosclerosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Collapsing FSGS in the kidney biopsy report. 2. Sickle cell disease. 3. HbA1c >8%. 4. Uncontrolled hypertension (≥160/100 millimeters of mercury).
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Placebo Comparator Placebo |
Matching placebo will be administered daily for 24 weeks |
|
Recruiting Locations
Investigator Site #2
Chula Vista, California 91910
Chula Vista, California 91910
Investigator Site #14
Los Angeles, California 90022
Los Angeles, California 90022
Investigator Site #12
San Dimas, California 91773
San Dimas, California 91773
Investigator Site #13
Arvada, Colorado 80002
Arvada, Colorado 80002
Investigator Site #17
Boca Raton, Florida 33431
Boca Raton, Florida 33431
Investigator Site #6
Coral Springs, Florida 33071
Coral Springs, Florida 33071
Investigator Site #7
Miami, Florida 33172
Miami, Florida 33172
Investigator Site #8
Orlando, Florida 32806
Orlando, Florida 32806
Investigator Site # 1
Lawrenceville, Georgia 30046
Lawrenceville, Georgia 30046
Investigator Site #11
Louisville, Kentucky 40205
Louisville, Kentucky 40205
Investigator Site #15
Livonia, Michigan 48152
Livonia, Michigan 48152
Investigator Site #10
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Investigator Site #16
New Bern, North Carolina 28562
New Bern, North Carolina 28562
Investigator Site #20
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Investigator Site #19
Bridgeville, Pennsylvania 15017
Bridgeville, Pennsylvania 15017
Investigator Site #22
Butler, Pennsylvania 16001
Butler, Pennsylvania 16001
Investigator Site #23
Goose Creek, South Carolina 29445
Goose Creek, South Carolina 29445
Investigator Site #4
Chattanooga, Tennessee 37404
Chattanooga, Tennessee 37404
Investigator Site #5
Arlington, Texas 76015
Arlington, Texas 76015
Investigator Site #21
Dallas, Texas 75230
Dallas, Texas 75230
Investigator Site #9
Dallas, Texas 75231
Dallas, Texas 75231
Investigator Site #18
Houston, Texas 48152
Houston, Texas 48152
More Details
- Status
- Recruiting
- Sponsor
- Akebia Therapeutics