RecruitingPhase 3NCT07498335

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN

A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)

Sponsor

Novartis Pharmaceuticals

Enrollment

28 participants

Start Date

Aug 26, 2026

Study Type

INTERVENTIONAL

Conditions

IgA Nephropathy Immunoglobulin A Nephropathy Berger Disease Bergers Disease Primary IgAN Nephritis IgA Type, Nephropathy IgA Type

Summary

A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \<18 years with primary immunoglobulin A nephropathy (IgAN).

Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Drug: Atrasentan for people with berger disease, bergers disease, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 2 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDrug: Atrasentan

* 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627

Locations(6)

Hackensack Meridian Health

Neptune City, New Jersey, United States

Cincinnati Childrens Hospital MC

Cincinnati, Ohio, United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

University of Tennessee Health Science Center- Le Bonheur Research Center

Memphis, Tennessee, United States

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Fukuoka, Japan

View Full Details on ClinicalTrials.gov

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NCT07498335

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