ACTIVE_NOT_RECRUITING

A Study of Zigakibart in Adults With IgA Nephropathy

Conditions

IgA Nephropathy Immunoglobulin A Nephropathy Kidney Diseases Kidney Diseases, Chronic Urological Diseases Glomerulonephritis Glomerular Disease Glomerulonephritis, IGA Glomerulopathy Immunoglobulin Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)

Quick Facts

Study Start:2023-07-06

Study Completion:2028-06-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05852938

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. * Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor. * eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation. * Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory. * Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study. * Screening weight of 45 to 150 kg. * Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group \[CTFG\] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated \> 1 month prior to first dose of study drug. * Provide written informed consent and be willing to comply with study visits and procedures.	* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias. * Diagnosis of IgA Vasculitis. * Current or history of nephrotic syndrome. * Average blood pressure \> 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator. * Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines * Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN. * History of Type 1 Diabetes. * Participants with Type 2 diabetes are excluded if any of the following are present: * Screening HbA1c (glycated hemoglobin) of \> 8%. * Evidence of diabetic changes on kidney biopsy, performed for any reason. * History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease). * Unstable anti-diabetic regimen: * Prior exposure to any therapy directed against APRIL. * History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody. * Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening. * Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening. * Use of systemic immunosuppressant medications. * Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants. * Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator. * Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening. * Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug. * History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A participant with curatively treated cervical carcinoma in situ is eligible for the study. Participants with low-risk prostate cancer (i.e., Gleason score \< 7 and prostate specific antigen \< 10 ng/mL) are allowed. * Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose. * History or evidence of any other clinically significant disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the participant at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results. * IgG levels \< 6 g/L at Screening. * Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.

Inclusion Criteria

Exclusion Criteria

* Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
* eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation.
* Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
* Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.
* Screening weight of 45 to 150 kg.
* Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group \[CTFG\] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated \> 1 month prior to first dose of study drug.
* Provide written informed consent and be willing to comply with study visits and procedures.

* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
* Diagnosis of IgA Vasculitis.
* Current or history of nephrotic syndrome.
* Average blood pressure \> 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator.
* Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines
* Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.
* History of Type 1 Diabetes.
* Participants with Type 2 diabetes are excluded if any of the following are present:
* Screening HbA1c (glycated hemoglobin) of \> 8%.
* Evidence of diabetic changes on kidney biopsy, performed for any reason.
* History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease).
* Unstable anti-diabetic regimen:
* Prior exposure to any therapy directed against APRIL.
* History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody.
* Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.
* Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening.
* Use of systemic immunosuppressant medications.
* Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants.
* Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.
* Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening.
* Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.
* History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A participant with curatively treated cervical carcinoma in situ is eligible for the study. Participants with low-risk prostate cancer (i.e., Gleason score \< 7 and prostate specific antigen \< 10 ng/mL) are allowed.
* Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
* History or evidence of any other clinically significant disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the participant at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results.
* IgG levels \< 6 g/L at Screening.
* Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham: The Kirklin Clinic

Birmingham, Alabama, 35233-1926

United States

Nephrology Consultants, LLC

Huntsville, Alabama, 35805-4104

United States

University of California, San Francisco

San Francisco, California, 94143

United States

Valiance Clinical Research

South Gate, California, 90280-5219

United States

University of Colorado Hospital

Aurora, Colorado, 80045

United States

Denver Nephrology Research Division

Denver, Colorado, 80230-6441

United States

Vida Medical Centers - Pembroke Pines

Pembroke Pines, Florida, 33023-2213

United States

NorthShore University HealthSystem

Evanston, Illinois, 60201-1700

United States

Nephrology Associales of Northern Illinois and Indiana

Hinsdale, Illinois, 60521-3640

United States

Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd

Fort Wayne, Indiana, 46804

United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242-1009

United States

Intermed Consultants

Edina, Minnesota, 55435-2129

United States

Capital District Renal Physicians

Clifton Park, New York, 12065

United States

Nephrology Associates PC - Flushing

Flushing, New York, 11355-5045

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6504

United States

University of Cincinnati College of Medicine - 231 Albert Sabin Way

Cincinnati, Ohio, 45267-2827

United States

Cleveland Clinic-9500 Euclid Ave

Cleveland, Ohio, 44109-1900

United States

OHSU - Oregon Clinical and Translational Research Institute

Portland, Oregon, 97239

United States

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania, 18017-2159

United States

Columbia Nephrology Associates , P.A. - Columbia

Columbia, South Carolina, 29203-6476

United States

Knoxville Kidney Center, PLLC - Frenova F1

Knoxville, Tennessee, 37923

United States

Dallas Renal Group - 1411 N Beckley Ave

Dallas, Texas, 75230

United States

Dallas Renal Group - Waxachie - 2460 N. I-35

Dallas, Texas, 75237-3461

United States

DaVita Clinical Research

El Paso, Texas, 79925

United States

University of Texas MD Anderson Cancer Center-1155 Pressler

Houston, Texas, 77030-2348

United States

East Texas Nephrology Associates

Lufkin, Texas, 75904-3132

United States

Nephrology Associates of Northern Virginia-8501 Arlington Blvd

Fairfax, Virginia, 22033-1907

United States

Swedish Center for Comprehensive Care

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-06

Study Completion Date2028-06-07

Study Record Updates

Study Start Date2023-07-06

Study Completion Date2028-06-07

Terms related to this study

Keywords Provided by Researchers

Kidney Diseases
Kidney Diseases, Chronic
Urological Diseases
Glomerulonephritis
Glomerular Disease
Glomerulonephritis, IGA
Glomerulopathy
Immunoglobulin Disease

Additional Relevant MeSH Terms

IgA Nephropathy
Immunoglobulin A Nephropathy