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).
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.
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.
Sequential
Drug: Atrasentan
Drug* 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627
Change From Baseline in Proteinuria at Week 36
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36
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
All cohorts combined
PK parameters: Cmaxss
Cmaxss: The maximum (peak) observed plasma concentration (mass x volume-1)
PK parameters: AUCss
AUCss: The AUC calculated during a dosing interval at steady state (amount x time x volume-1)
PK parameters: CLss/F
CLss/F: Apparent total plasma clearance of after extravascular administration at steady state. (volume x time-1)
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