NCT06797518 · Novartis Pharmaceuticals
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
What this study is about
A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months.
View original scientific description
A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months.
Interventions
DRUG
Iptacopan
LNP023 oral capsule 200 mg b.i.d
Primary outcome measures
Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.
Time frame: BSL, Month 9
Mesangial C3c deposition is assessed by intensity of immunofluorescence (IF) staining using the following grading system: 0 (absent) 1 (+) 2 (++) 3 (+++)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed informed consent must be obtained prior to participation in the study; participants should be able to communicate well with the investigator, understand and comply with the requirements of the study. 2. Male and female participants ≥18 years of age with biopsy-confirmed IgA nephropathy and an eGFR ≥ 30 mL/min/1.73m2. eGFR will be calculated using the CKD-EPI 2009 formula. 3. Proteinuria as assessed at screening by UPCR ≥ 0.8g/g or 1g/d sampled from FMV. 4. Biopsy at baseline should confirm IgAN with \< 50% tubulointerstitial fibrosis. 5. Participants must be on ACEi or ARB treatment at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for approximately 90 days prior to baseline visit and continue on a stable dose throughout the study. Participants with allergies or intolerance to ACEi and ARB are eligible for the study, but the investigator should clearly document the reasons for not being on maxi
Where
- Birmingham, Alabama
- Los Angeles, California
- Orlando, Florida
- Lawrenceville, Georgia
- Chubbuck, Idaho
- Las Vegas, Nevada
- Cleveland, Ohio
- Columbus, Ohio
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations