Phase 3: testing Drug: Atrasentan for Berger Disease
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).
Official registry: https://clinicaltrials.gov/study/NCT07498335 · Novartis Pharmaceuticals · enrollment listed as 28
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Drug: Atrasentan. The registry lists allocation as randomized. 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).
They plan to enroll about 28 people at 22 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)
Interventions: Drug: Atrasentan
Primary outcome (registry wording): Change From Baseline in Proteinuria at Week 36
Who it is for (from inclusion criteria)
- Ages 2 Years to 18 Years
- 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
- 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
Who the registry excludes
- 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
- 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
Public study contact (from the registry)
Novartis Pharmaceuticals
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
22 listed- Hackensack Meridian Health — Neptune City, New Jersey (not_yet_recruiting)
- Cincinnati Childrens Hospital MC — Cincinnati, Ohio (not_yet_recruiting)
- University of Oklahoma Health Science Center — Oklahoma City, Oklahoma (not_yet_recruiting)
- University of Tennessee Health Science Center- Le Bonheur Research Center — Memphis, Tennessee (not_yet_recruiting)
+ 18 sites outside the US on the same record
FAQ about this NCT record
Is NCT07498335 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07498335?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07498335?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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