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

Part of paid clinical trials in Neptune City, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07498335
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Drug: Atrasentan — DRUG
    * 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627

Study Details

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).

Key Dates

First listed
Mar 27, 2026
Start date
Aug 26, 2026
Status verified
Jul 2026
Primary completion
Sep 15, 2031
Completion
Dec 13, 2032

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (≥40 kg of body weight)
    Once daily oral administration of 0.75 mg atrasentan for 104 weeks
  • Experimental: Cohort 2 (30 to <40 kg of body weight)
    Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks
  • Experimental: Cohort 3 (20 to <30 kg of body weight)
    Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks
  • Experimental: Cohort 4 (10 to <20kg of body weight)
    Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks

Primary Outcome Measure

Change From Baseline in Proteinuria at Week 36 [ Time Frame: Baseline and 36 weeks ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (4)

FacilityCityStateZIPSite coordinators
Hackensack Meridian HealthNeptune CityNew Jersey07753-
Cincinnati Childrens Hospital MCCincinnatiOhio45229-
University of Oklahoma Health Science CenterOklahoma CityOklahoma73104-
University of Tennessee Health Science Center- Le Bonheur Research CenterMemphisTennessee38105-

Find similar trials in Neptune City, NJ

By research site
Hackensack Meridian Health· Neptune City, NJCincinnati Childrens Hospital MC· Cincinnati, OHUniversity of Oklahoma Health Science Center· Oklahoma City, OKUniversity of Tennessee Health Science Center- Le Bonheur Research Center· Memphis, TN

Related Studies