Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Pat… (NCT06797518) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
United States20 participantsStarted 2025-02-21
Plain-language summary
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 can participate
Age range18 Years – 99 Years
SexALL
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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.
✓. 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.
✓. 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 maximal ACEi/ARB dose in the source documents. In addition, if participants are taking diuretics, other antihypertensive medication or Sodium-Glucose Co-Transporter 2 inhibitors (SGLT2i), the doses should be stabilized for at least 90 days prior to baseline.
✓. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections required to be completed at least 2 weeks prior to the start of study treatment. If the participants have not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment must start earlier than 2 weeks post-vaccination, prophylactic antibiotic treatment should be initiated.
What they're measuring
1
Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.
✓. Vaccination against Haemophilus influenzae infection should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration.
Exclusion criteria
✕. 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.
✕. Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of screening.
✕. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening, or presence of nephrotic syndrome.
✕. Sitting office SBP \>140 mmHg or DBP \>90 mmHg at the screening visit.
✕. Participants treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, systemic corticosteroids exposure (\>7.5 mg/d prednisone/prednisolone equivalent) or targeted release formulation (TRF) of budesonide within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants using other medication such us hydroxychloroquine or Endothelin receptor antagonists (ERAs).