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

Withdrawn before enrolling · Phase 2

Conditions studied: Nephrotic Syndrome

In brief

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

Key facts

Study ID

NCT05599815

Run by

Aldeyra Therapeutics, Inc.

People needed

0

Starts

2023-01-01

Expected to finish

2023-05-01

Last updated by the study team

2024-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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