Part 1 - A Clinical Trial in Patients With Frequently Rel... | NCT05599815

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment.

Expanded Access Info

Start Date

Jan 2023Estimated

Primary Completion Date

May 2023Estimated

Completion Date

May 2023Estimated

First Submitted Date

Oct 26, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
ADX-629	Experimental		Drug: ADX-629

Name	Type	Description	Arm Group Labels	Other Names
ADX-629	Drug	ADX-629 (250 milligrams) administered twice daily	ADX-629

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Event (AE) Query	Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	From Day 1 to Day 90

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amicis Research Center - Northridge		Northridge	California	91324	United States
University of Colorado

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39513526	Derived	Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

ID	Term
D009404	Nephrotic Syndrome
D009402	Nephrosis, Lipoid
D005923	Glomerulosclerosis, Focal Segmental
D051436	Renal Insufficiency, Chronic

ID	Term
D009401	Nephrosis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D005921	Glomerulonephritis
D009393	Nephritis
D051437	Renal Insufficiency
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms