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

NCT07498335 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CEXV811B12301
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 6

Brief 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).

Conditions

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

Keywords

Kidney Diseases; Kidney Disease, Chronic; Glomerulonephritis; Urologic Diseases; Glomerular Disease; Glomerulonephritis, IGA; Glomerulopathy; Immunoglobulin Disease; Atrasentan

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Proteinuria at Week 36

  The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36

  Baseline and 36 weeks

Secondary Outcomes (6)

• Change from Baseline in Proteinuria at Week 36 in participants who experienced ≤ 30% decrease in proteinuria during the 60-day period prior to atrasentan initiation

  Baseline and 36 weeks

• PK parameters: Cmaxss

  Baseline and week 104

• PK parameters: AUCss

  Baseline and week 104

• PK parameters: CLss/F

  Baseline and week 104

• PK parameters: Ctrough

  Baseline and week 104

Study Arms (4)

Cohort 1 (≥40 kg of body weight)

EXPERIMENTAL

Once daily oral administration of 0.75 mg atrasentan for 104 weeks

Drug: Drug: Atrasentan

Cohort 2 (30 to <40 kg of body weight)

EXPERIMENTAL

Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks

Drug: Drug: Atrasentan

Cohort 3 (20 to <30 kg of body weight)

EXPERIMENTAL

Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks

Drug: Drug: Atrasentan

Cohort 4 (10 to <20kg of body weight)

EXPERIMENTAL

Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks

Drug: Drug: Atrasentan

Interventions

Drug: Atrasentan DRUG

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

Cohort 1 (≥40 kg of body weight); Cohort 2 (30 to <40 kg of body weight); Cohort 3 (20 to <30 kg of body weight); Cohort 4 (10 to <20kg of body weight)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants depending upon their age and local requirement.
• Male and female participants 2 to \< 18 years of age as of Day 1.
• eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
• Kidney biopsy-proven primary IgAN\*, with biopsy performed within 3 years of Screening with \< 50% tubulointerstitial fibrosis and \< 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.
• Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor/ARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.
• All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per Investigator's judgment for pediatric use), for at least 120 days before first study drug administration. In addition, if participants are taking diuretics, other antihypertensive medication, or other background medication for IgAN (such as SGLT2 inhibitors), the doses should also be stabilized for at least 120 days prior to the first dosing of study treatment. Note: Participants with allergies or intolerance to ACE inhibitors and ARBs are eligible for the study. Participants with allergies or intolerance to RAS inhibitors are eligible but will not exceed \~5% of the total population treated (maximum of 2 participants).
• The minimum body weight of enrolled pediatric participants is 10 kg at Screening and confirmed on Day 1.
• Parent(s)/guardian(s) are to be able to communicate well with the investigator and to understand and comply with the study's requirements for their child.

You may not qualify if:

• Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is longer; or longer if required by local regulations.
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
• Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, Herpes Simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever before treatment.
• A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.
• Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline/Day 1.
• Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration.
• Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of Screening.
• Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during Screening and Run-in periods.
• Presence of nephrotic syndrome at Screening based on the investigator's judgement.
• BNP value of \>200 pg/mL at Screening.
• Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia within 3 months of Screening.
• Platelet count \<80,000/μL at Screening.
• On Day 1 participants' body weight falls below the lower limit of the cohort in which the participant was initially screened and lower body weight cohort is not open for enrollment.
• Known history of congenital heart disease, heart failure or clinically significant fluid retention such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites before treatment.
• Current use of any homeopathic and/or herbal medications for the treatment of IgAN disease , such as but not limited to Tripterygium wilfordii (Lei Gong Teng), Caulis sinomenii and Sinomenium acutum before treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Hackensack Meridian Health

Neptune City, New Jersey, 07753, United States

NOT YET RECRUITING

Cincinnati Childrens Hospital MC

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

NOT YET RECRUITING

University of Tennessee Health Science Center- Le Bonheur Research Center

Memphis, Tennessee, 38105, United States

NOT YET RECRUITING

Novartis Investigative Site

Nagoya, Aichi-ken, 4578510, Japan

RECRUITING

Novartis Investigative Site

Fukuoka, 815-8555, Japan

RECRUITING

Related Publications (1)

• Heerspink HJL, Jardine M, Kohan DE, Lafayette RA, Levin A, Liew A, Zhang H, Lodha A, Gray T, Wang Y, Renfurm R, Barratt J; ALIGN Study Investigators. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025 Feb 6;392(6):544-554. doi: 10.1056/NEJMoa2409415. Epub 2024 Oct 25.

  PMID: 39460694 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Diseases; Renal Insufficiency, Chronic; Glomerulonephritis; Urologic Diseases

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Nephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): August 26, 2026
• Primary Completion (Estimated): September 15, 2031
• Study Completion (Estimated): December 13, 2032
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (4); JP (2)