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

ConditionsGlomerulonephritis, IGAImmunoglobulin A Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Proteinuria as assessed at screening by UPCR ≥ 0.8g/g or 1g/d sampled from FMV.

Biopsy at baseline should confirm IgAN with < 50% tubulointerstitial fibrosis.

Disqualifiers

Any secondary IgAN (at historic or baseline biopsies) as defined by the investigator and IgA vasculitis Henoch-Scholein Purpura (HSP). Secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial Mediterranean fever, etc.

Any secondary diagnosis at baseline biopsy (other than IgA nephropathy).

Evidence of significant urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before first study drug administration.

Current or planned usage of any homeopathic and/or herbal medications for IgAN disease progression, such as but not limited to Lei Gong Teng.

Trial design

Design model

Single group

Treatments tested in this trial

  • Iptacopan

    Drug

    LNP023 oral capsule 200 mg b.i.d

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: IptacopanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.

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

Time frame
BSL, Month 9

Secondary outcomes

1

Change from baseline at 9 months in CD68 cells

To describe the histopathological changes in additional biomarkers after treatment with iptacopan

Time frame
BSL, Month 9
2

Change from baseline at 9 months in staining of Immunoglobulins (IgA and IgG)

To describe the histopathological changes in additional biomarkers after treatment with iptacopan

Time frame
BSL, Month 9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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