Atrasentan for Children and Teens with Primary IgA Nephropathy
This study is testing a medication called atrasentan (also known as Atrasentan Hydrochloride or ABT-627) in children and teenagers with primary IgA nephropathy (IgAN), sometimes called Berger's Disease. IgAN is a kidney disease. The study aims to see how well atrasentan works, how safe it is, and how the body uses it. You might be able to join if you are between 2 and 18 years old, have IgAN confirmed by a biopsy, and your kidney function (eGFR) is at least 30 mL/min. The main goal is to see if atrasentan can reduce the amount of protein in your urine (proteinuria) after 36 weeks. The study plans to enroll 28 participants, but its current recruitment status is unclear.
- Study design
- This is a Phase III, single-arm study, meaning all participants will receive atrasentan. It plans to enroll 28 children and teenagers.
- What's involved
- Participants will take atrasentan tablets for up to 104 weeks. You will also have regular visits to measure protein in your urine and check your safety.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 36 weeks, and safety data will be collected for up to 104 weeks.
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NCT07498335
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Recruiting
PHASE3Ages 2–18InterventionalTreatmentNovartis Pharmaceuticals
~28 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Drug: Atrasentan
At a glance
Recruiting sites
2 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Proteinuria at Week 36
Measured over Baseline and 36 weeks
Conditions
Where it's being run
6 sites across 6 statesNew Jersey1
Ohio1
Oklahoma1
Tennessee1
Aichi-ken1
Japan1
Study leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3X upper limit of normal (ULN)
Serum bilirubin must not exceed 2X ULN 26. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases; for children aged 2 to \<5 years of age, history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, inclusive of malignancies diagnosed at birth and during the neonatal and childhood time, regardless of whether there is evidence of local recurrence or metastases. 27. Pregnant or nursing (lactating) female participants (of childbearing potential), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test at Screening. 28. Subjects taking prohibited therapies before treatment. 29. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for 1 month after stopping study treatment.
Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.
Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment).
Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical success.
Use of hormonal contraception methods:
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.
Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.
Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment. If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF. 30. For fertile male participants, participants must not intend to father a child or donate sperm while taking study treatment and at least 1 month afterward for males.
All fertile male participants in a sexual relationship with a WOCBP must agree to the use of a condom during the trial and for up to one month after last study drug administration. A male participant is considered fertile after puberty unless permanently sterile by bilateral orchidectomy/orchiectomy.
What this trial measures
- Change From Baseline in Proteinuria at Week 36Baseline and 36 weeks
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36