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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07498335
Phase
PHASE3
Status
Not Yet Recruiting

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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

Start date
Aug 26, 2026
Status verified
May 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

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