Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Study Overview
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Northridge, California, United States, 91324
- Amicis Research Center - Northridge
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado
-
-
Florida
-
Lauderdale Lakes, Florida, United States, 33309
- South Florida Research Institute
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University - Pediatric Nephrology
-
Bremen, Georgia, United States, 30110
- ClinCept, LLC
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71101
- Northwest Louisiana Nephrology
-
-
Nevada
-
Las Vegas, Nevada, United States, 88901
- Nevada Kidney Disease Hypertension Center (NKDHC)
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- East Carolina University - Nephrology
-
-
Ohio
-
Columbus, Ohio, United States, 43004
- The Ohio State University (OSU) Wexner Medical Center
-
Toledo, Ohio, United States, 43537
- University of Toledo Medical Center
-
-
Utah
-
Saint George, Utah, United States, 84765
- Southern Utah Kidney and Hypertension Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ADX-629
|
ADX-629 (250 milligrams) administered twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Event (AE) Query
Time Frame: From Day 1 to Day 90
|
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
|
From Day 1 to Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relapse Frequency
Time Frame: From Day 1 to Day 90
|
Proportion of subjects with one or more relapse(s), as defined by treatment with corticosteroid therapy
|
From Day 1 to Day 90
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADX-629-MCD-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.