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

Nephrotic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05599815
• Other study ID #: ADX-629-MCD-001
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2023
• Est. completion date: May 2023

Study information

• Verified date: April 2024
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

Drug:
• ADX-629
ADX-629 (250 milligrams) administered twice daily

Locations

Country	Name	City	State
United States	Emory University - Pediatric Nephrology	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	ClinCept, LLC	Bremen	Georgia
United States	The Ohio State University (OSU) Wexner Medical Center	Columbus	Ohio
United States	East Carolina University - Nephrology	Greenville	North Carolina
United States	Nevada Kidney Disease Hypertension Center (NKDHC)	Las Vegas	Nevada
United States	South Florida Research Institute	Lauderdale Lakes	Florida
United States	Amicis Research Center - Northridge	Northridge	California
United States	Southern Utah Kidney and Hypertension Center	Saint George	Utah
United States	Northwest Louisiana Nephrology	Shreveport	Louisiana
United States	University of Toledo Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relapse Frequency	Proportion of subjects with one or more relapse(s), as defined by treatment with corticosteroid therapy	From Day 1 to Day 90