Clinical trial NCT05599815: Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Official title: A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Nephrotic Syndrome
Keywords: Idiopathic nephrotic syndrome
Focal segmental glomerulosclerosis (FSGS)
Minimal change disease
Frequently relapsing nephrotic syndrome
ADX-629
Reactive aldehyde species (RASP)
Chronic kidney disease
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome

Detailed description: ADX-629-MCD-001 is a multi-center, two-part, Phase 2 clinical trial designed to evaluate the safety and efficacy of ADX-629 in Subjects with frequently relapsing and steroid-dependent nephrotic syndrome. Study drug will be administered orally every 12 hours (twice daily) to eligible subjects for 90 days. The study will enroll approximately 35 children and adults with nephrotic syndrome who have had a nephrotic relapse in the 6 months prior to screening.

The clinical trial is divided into 2 parts: Part 1 (open-label) and Part 2 (double-blinded, randomized).

Part 1: Approximately 5 eligible subjects will receive open-label ADX-629 (250 mg) twice daily for 90 days.

Part 2: Approximately 30 eligible subjects will be randomized in a 2:1 ratio to receive either ADX-629 (250 mg) or matching placebo twice daily for 90 days.

Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years of age
* History of nephrotic syndrome, characterized by heavy proteinuria and hypoalbuminemia
* Recent nephrotic relapse in the 6 months prior to screening
* Estimated glomerular filtration rate (eGFR) of ≥45 during screening
* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable

Exclusion Criteria:

* Subjects with collapsing FSGS focal segmental glomerulosclerosis (FSGS)
* Known secondary cause of nephrotic syndrome (e.g., diabetic nephropathy, systemic lupus erythematous, sickle cell anemia, malignancy, drug-induced, malaria)
* History of kidney transplantation or other solid organ transplantation
* History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial

Primary outcomes:
measure: Adverse Event (AE) Query
timeFrame: From Day 1 to Day 90
Secondary outcomes:
measure: Relapse Frequency
timeFrame: From Day 1 to Day 90
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Amicis Research Center - Northridge
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University - Pediatric Nephrology
state: Georgia
city: Bremen
country: United States
facility: ClinCept, LLC
state: Georgia
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Las Vegas
country: United States
facility: Nevada Kidney Disease Hypertension Center (NKDHC)
state: Nevada
city: Greenville
country: United States
facility: East Carolina University - Nephrology
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University (OSU) Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Saint George
country: United States
facility: Southern Utah Kidney and Hypertension Center
state: Utah
Study officials:
References: