RECRUITING

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

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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

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.

Official Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression

Quick Facts

Study Start:2023-08-08

Study Completion:2030-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05797610

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
* Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause * Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications * Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g/g) or urine protein excretion ≥ 1 gram per day (g/day) (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening * eGFR ≥ 20 mL/min/1.73 m\^2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (Inker et al. 2021a) * Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations * Female participants of childbearing potential must use adequate contraception	* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen * Histopathologic or other evidence of another autoimmune glomerular disease * Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator * History of kidney transplantation * Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type * Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg from the average of two measurements performed at least 1 minute apart during screening * Initiation of SGLT2 inhibitors within 16 weeks prior to screening or during screening * Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening * Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening * Use of herbal therapies within 90 days prior to or during screening * Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening * Treatment with an investigational therapy planned during the treatment period * Previous treatment with sefaxersen * Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to ≥ 5 mg/day of prednisone for 14 days within 90 days prior to screening * Treatment with corticosteroids with systemic effects during screening * Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening * Treatment with anti-CD20 therapy within 9 months of screening or during screening * Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate * Planned major procedure or major surgery during screening or the study * Substance abuse within 12 months prior to screening or during screening * Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study * History of malignancy within \< 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Usage of GLP-1-based therapy (i.e., GLP-1 mono-agonists, GLP-1/GIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period

Inclusion Criteria

Exclusion Criteria

* Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause
* Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications
* Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g/g) or urine protein excretion ≥ 1 gram per day (g/day) (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening
* eGFR ≥ 20 mL/min/1.73 m\^2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (Inker et al. 2021a)
* Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations
* Female participants of childbearing potential must use adequate contraception

* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen
* Histopathologic or other evidence of another autoimmune glomerular disease
* Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator
* History of kidney transplantation
* Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
* Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg from the average of two measurements performed at least 1 minute apart during screening
* Initiation of SGLT2 inhibitors within 16 weeks prior to screening or during screening
* Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening
* Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening
* Use of herbal therapies within 90 days prior to or during screening
* Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening
* Treatment with an investigational therapy planned during the treatment period
* Previous treatment with sefaxersen
* Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to ≥ 5 mg/day of prednisone for 14 days within 90 days prior to screening
* Treatment with corticosteroids with systemic effects during screening
* Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening
* Treatment with anti-CD20 therapy within 9 months of screening or during screening
* Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate
* Planned major procedure or major surgery during screening or the study
* Substance abuse within 12 months prior to screening or during screening
* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
* History of malignancy within \< 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Usage of GLP-1-based therapy (i.e., GLP-1 mono-agonists, GLP-1/GIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period

Contacts and Locations

Study Contact

WA43966 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

UAB Nephrology Research Clinic

Birmingham, Alabama, 35233

United States

Onyx Clinical Research LLC Peoria

Peoria, Arizona, 85381

United States

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, 85710

United States

Southern California Medical Research Center

La Palma, California, 90623

United States

Academic Medical Research Institute - Los Angeles

Los Angeles, California, 90022

United States

North America Research Institute-San Dimas

San Dimas, California, 91773

United States

Hope Clinic & Research Center

Hialeah, Florida, 33010

United States

LCC Medical Research - Miami - ClinEdge - PPDS

Miami, Florida, 33126

United States

L&C Professional Medical Research Institute

W. Miami, Florida, 33144

United States

Cowry Medical Group LLC

Acworth, Georgia, 30101

United States

Care Institute Idaho Kidney Institute

Chubbuck, Idaho, 83202

United States

Nephrology Associates of Northern Illinois

Hinsdale, Illinois, 60521

United States

University of Iowa

Iowa City, Iowa, 52242

United States

Massachussets General Hospital

Boston, Massachusetts, 02114

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Sierra Nevada Nephrology Consultants

Reno, Nevada, 89511

United States

NYU Langone Nephrology Associates - Mineola

Mineola, New York, 11501

United States

North Carolina Nephrology, PA

Raleigh, North Carolina, 27609

United States

Ohio State University Wexner Medical Center - Outpatient Care East

Columbus, Ohio, 43203

United States

Kidney and Hypertension Center

Roseburg, Oregon, 97471

United States

Global Medical Research - M3 WR

Dallas, Texas, 75224

United States

Texas Kidney Institute - Dallas

Dallas, Texas, 75231

United States

Pioneer Research Solutions

Houston, Texas, 077099

United States

Prolato Clinical Research Center

Houston, Texas, 77054

United States

R & H Clinical Research

Katy, Texas, 77450

United States

Revival Research Corporation - Sherman - ClinEdge - PPDS

Sherman, Texas, 75092

United States

Nephrology Associates of Northern Virginia Inc

Fairfax, Virginia, 22033

United States

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Milwaukee Nephrologists, Sc

Wauwatosa, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

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 Date2023-08-08

Study Completion Date2030-09-30

Study Record Updates

Study Start Date2023-08-08

Study Completion Date2030-09-30

Terms related to this study

Additional Relevant MeSH Terms

Primary IgA Nephropathy