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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05599815

Collaborator

(none)

Enrollment

Locations

Arm

3.9

Anticipated Duration (Months)

0.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome	Drug: ADX-629	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADX-629	Drug: ADX-629 ADX-629 (250 milligrams) administered twice daily

Arm

Intervention/Treatment

Experimental: ADX-629

Drug: ADX-629

ADX-629 (250 milligrams) administered twice daily

Outcome Measures

Primary Outcome Measures

Adverse Event (AE) Query [From Day 1 to Day 90]
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Relapse Frequency [From Day 1 to Day 90]
Proportion of subjects with one or more relapse(s), as defined by treatment with corticosteroid therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amicis Research Center - Northridge	Northridge	California	United States	91324
2	University of Colorado	Aurora	Colorado	United States	80045
3	South Florida Research Institute	Lauderdale Lakes	Florida	United States	33309
4	Emory University - Pediatric Nephrology	Atlanta	Georgia	United States	30322
5	ClinCept, LLC	Bremen	Georgia	United States	30110
6	Northwest Louisiana Nephrology	Shreveport	Louisiana	United States	71101
7	Nevada Kidney Disease Hypertension Center (NKDHC)	Las Vegas	Nevada	United States	88901
8	East Carolina University - Nephrology	Greenville	North Carolina	United States	27834
9	The Ohio State University (OSU) Wexner Medical Center	Columbus	Ohio	United States	43004
10	University of Toledo Medical Center	Toledo	Ohio	United States	43537
11	Southern Utah Kidney and Hypertension Center	Saint George	Utah	United States	84765