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Study of Iptacopan for IgA Nephropathy

This study is looking at how a drug called iptacopan affects adults with IgA nephropathy (IgAN), a kidney disease. You might be able to join if you are at least 18 years old and have IgAN confirmed by a biopsy, with a kidney function (eGFR) of 30 or higher. The study will give participants iptacopan 200 mg twice a day for nine months. Researchers will measure changes in a specific protein (complement C3c) in kidney biopsies to see if the treatment is working. The study aims to understand how iptacopan impacts the disease in the kidneys and the body overall. The current recruitment status is unclear, and the study plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a single-arm study, with 20 planned participants.
What's involved
You would have a screening period, a baseline visit with a kidney biopsy, take iptacopan for 9 months, and then have another kidney biopsy at the end of the study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 9 months, with a final biopsy at the end of this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06797518

Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN

Recruiting
PHASE2Ages 18–99InterventionalTreatment
Novartis Pharmaceuticals
~20 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Iptacopan

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.
Measured over BSL, Month 9

Conditions

Glomerulonephritis, IGA
Immunoglobulin A Nephropathy

Explore related trials

IgA Nephropathy

Where it's being run

19 sites across 14 states
Israel4
Ohio2
Buenos Aires2
Alabama1
California1
Florida1
Georgia1
Idaho1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3 × upper limit of normal (ULN)
Serum bilirubin must not exceed 2 × ULN 20. 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. 21. Pregnant or nursing (lactating) women, 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. 22. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to use effective methods of contraception during dosing of investigational drug and for 1 week after stopping of investigational drug.
Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Male sterilization (at least 6 months prior to screening) of male partner of the female participant.
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/vaginal suppository.
Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.
If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF.
Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.
If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

What this trial measures

  • Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.BSL, Month 9

    Mesangial C3c deposition is assessed by intensity of immunofluorescence (IF) staining using the following grading system: 0 (absent) 1 (+) 2 (++) 3 (+++)