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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome

NCT03298698

Idiopathic Nephrotic Syndrome Minimal Change Disease Focal Segmental Glomerulosclerosis

UNKNOWN PHASE3

Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)

NCT01129284

Treatment Resistant Nephrotic Syndrome

COMPLETED PHASE4

Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted

NCT03832114

Glomerulonephritis

COMPLETED PHASE2

Safety and Efficacy of Combination Acthar Gel and Tacrolimus in the Treatment of Steroid Resistant Nephrotic Syndrome

NCT03042637

Nephrotic Syndrome

SUSPENDED

A Phase 2 Extension of Study GCS-100-CS-4003

NCT02333955

Chronic Kidney Disease

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nephrotic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADX-629

Group Type EXPERIMENTAL

ADX-629

Intervention Type DRUG

ADX-629 (250 milligrams) administered twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADX-629

ADX-629 (250 milligrams) administered twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No