A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN

Phase 2Not Yet RecruitingNCT07773727

argenx120 enrolled

Overview

The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN. While in the study, participants will continue to receive their usual medical care and medications for IgA nephropathy, unless the study doctor confirms otherwise. The study will include a double blinded period, followed by an active drug period, and conclude with a follow up period. The total study duration for participants will be approximately 72 weeks, with a maximum of 52 weeks on ARGX-121.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Immunoglobulin A Nephropathy (IgAN)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females (not pregnant) * At least 18 years old * Clinically diagnosed with IgAN with biopsy confirmation Exclusion Criteria: * Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN * Has secondary form of IgAN leading to IgA deposits * History of Malignancy * Active infection of concern * Recent Major surgery or organ transplant

Locations (3)

Bioresearch Partners

Miami, Florida, United States

Nephrology Associates of South Miami PA

Miami, Florida, United States

Kidney and Hypertension Specialists- Virginia

Manassas, Virginia, United States

Outcomes

Primary Outcomes

Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.

UPCR is urine protein-to-creatinine ratio

Time frame: Up to 24 weeks

Secondary Outcomes

Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52

Time frame: 52 weeks

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 68 weeks

Cmax (ARGX-121 maximum observed concentration) in serum

Time frame: Up to 68 weeks

Percentage change in total IgA from baseline over time in serum

Time frame: Up to 68 weeks

Percentage change in Gd-IgA1 from baseline over time in serum

Gd-IgA1 means galactose-deficient immunoglobulin A1

Time frame: Up to 68 weeks

Percentage change in total IgG from baseline over time in serum

Time frame: Up to 68 weeks

Incidence of antidrug antibodies (ADA) against ARGX-121 in serum

Time frame: Up to 68 weeks

A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts