Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome

NCT05599815 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: ADX-629-MCD-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Adverse Event (AE) Query

  Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  From Day 1 to Day 90

Secondary Outcomes (1)

• Relapse Frequency

  From Day 1 to Day 90

Study Arms (1)

ADX-629

EXPERIMENTAL

Drug: ADX-629

Interventions

ADX-629 DRUG

ADX-629 (250 milligrams) administered twice daily

ADX-629

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (11)

Amicis Research Center - Northridge

Northridge, California, 91324, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

South Florida Research Institute

Lauderdale Lakes, Florida, 33309, United States

Location

Emory University - Pediatric Nephrology

Atlanta, Georgia, 30322, United States

Location

ClinCept, LLC

Bremen, Georgia, 30110, United States

Location

Northwest Louisiana Nephrology

Shreveport, Louisiana, 71101, United States

Location

Nevada Kidney Disease Hypertension Center (NKDHC)

Las Vegas, Nevada, 88901, United States

Location

East Carolina University - Nephrology

Greenville, North Carolina, 27834, United States

Location

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, 43004, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43537, United States

Location

Southern Utah Kidney and Hypertension Center

St. George, Utah, 84765, United States

Location

Related Publications (1)

• Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

  PMID: 39513526 DERIVED

MeSH Terms

Conditions

Nephrotic Syndrome; Nephrosis, Lipoid; Glomerulosclerosis, Focal Segmental; Renal Insufficiency, Chronic

Interventions

ADX-629

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: January 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)