New study to track how kidney disease drugs work in real life
NCT ID NCT07481084
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will observe 80 adults with IgA nephropathy who are prescribed iptacopan or atrasentan as part of their routine care. Researchers will collect data on patient profiles, treatment patterns, and clinical outcomes over 24 months. The goal is to understand how these drugs perform in real-world settings and to contribute to a larger global analysis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iptacopan and atrasentan
- What this could lead to
- If successful, this study could provide real-world evidence on how iptacopan and atrasentan work in everyday practice, potentially guiding better treatment decisions for IgA nephropathy.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by patient differences. It is also small (80 participants) and only follows patients for 24 months, limiting generalizability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with IgAN (≥18 years) to be treated with iptacopan or atrasentan in the real-world setting
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. Biopsy confirmed diagnosis of IgAN. 2. Age ≥18 years at index date. 3. Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician. 4. Able to provide written consent for participation. a. Patients who withdraw their consent will be censored on this date; all aggregated and anonymised data collected up to that date will be included in a centralised IgNITE data platform. Exclusion criteria 1. Use of investigational drugs during the study, OR within 3 months before index date, OR within 5 half-lives of investigational drug before index date, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer. 2. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan. 3. Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records. 4. Presence of significant comorbidities or conditions that may impact the interpretation of the study results or the patient's ability to participate in the study at the discretion of treating physician. 5. Pregnancy or other contraindications for iptacopan and/or atrasentan 6. Insufficient medical records available for the baseline and follow-up periods.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a transplant drug tame stubborn kidney disease?
- Blood marker may foretell kidney disease severity
- Can a massive kidney database unlock IgA Nephropathy's secrets?
- Can a new injection slow kidney disease in children?