Overview

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

Status:
Not yet recruiting

Trial end date:
2023-05-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Aldeyra Therapeutics, Inc.

Criteria

Inclusion Criteria:

- Children ≥9 years of age and 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