Iptacopan for IgA Nephropathy

Recruiting at 3 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: ACEi, ARB

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Secondary IgAN, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: 9 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quantifying the change in mesangial C3c containing fragments deposition, as an indicator of complement activation, and evaluating a variety of biomarkers related to kidney function, damage, and disease progression, including but not limited to Oxford MEST-C score.

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Adults with IgA Nephropathy (IgAN) who have protein in their urine and confirmed diagnosis by kidney biopsy. They must be vaccinated against certain infections or take antibiotics, able to give informed consent, communicate well, and follow study requirements. Participants should be on stable doses of specific blood pressure medicines for about 90 days before the trial.

Inclusion Criteria

I have been vaccinated against meningitis and pneumonia at least 2 weeks before starting the study treatment, or I will start antibiotics if I need to begin treatment sooner.

I have signed the consent form and can follow the study's requirements.

My protein levels in urine are high.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline visit with kidney biopsy performed

1 day

1 visit (in-person)

Treatment

Participants receive iptacopan 200 mg b.i.d for a 9-month treatment period

9 months

Monthly visits (in-person)

Follow-up

Follow-up biopsy performed at the end of study to assess changes

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Iptacopan

Trial Overview The trial is testing Iptacopan's effect on IgAN when added to standard care. It looks at changes in kidney tissue and disease markers over 9 months to understand how it affects immune responses and kidney health.

How Is the Trial Designed?

Group I: Iptacopan Experimental Treatment 1 Intervention

All the study participants will receive iptacopan 200 mg oral capsule b.i.d, while remaining on the maximally tolerated or locally approved maximal daily doses of ACEi/ARB throughout the treatment period.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD