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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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

  1. 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

ArmDescriptionAssigned 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.
  • Drug: Praliciguat
    Oral Tablet
Placebo Comparator
Placebo 		Matching placebo will be administered daily for 24 weeks
  • Other: Placebo
    Oral Tablet

Recruiting Locations

Investigator Site #2
Chula Vista, California 91910

Investigator Site #14
Los Angeles, California 90022

Investigator Site #12
San Dimas, California 91773

Investigator Site #13
Arvada, Colorado 80002

Investigator Site #17
Boca Raton, Florida 33431

Investigator Site #6
Coral Springs, Florida 33071

Investigator Site #7
Miami, Florida 33172

Investigator Site #8
Orlando, Florida 32806

Investigator Site # 1
Lawrenceville, Georgia 30046

Investigator Site #11
Louisville, Kentucky 40205

Investigator Site #15
Livonia, Michigan 48152

Investigator Site #10
Pontiac, Michigan 48341

Investigator Site #16
New Bern, North Carolina 28562

Investigator Site #20
Cleveland, Ohio 44106

Investigator Site #19
Bridgeville, Pennsylvania 15017

Investigator Site #22
Butler, Pennsylvania 16001

Investigator Site #23
Goose Creek, South Carolina 29445

Investigator Site #4
Chattanooga, Tennessee 37404

Investigator Site #5
Arlington, Texas 76015

Investigator Site #21
Dallas, Texas 75230

Investigator Site #9
Dallas, Texas 75231

Investigator Site #18
Houston, Texas 48152

More Details

Status
Recruiting
Sponsor
Akebia Therapeutics

Study Contact

Akebia Therapeutics
16178446128
trials@akebia.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.