Actively Recruiting
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
Led by Novartis Pharmaceuticals · Updated on 2026-04-27
20
Participants Needed
18
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to comply with study requirements
- Male or female aged 18 years or older with biopsy-confirmed IgA nephropathy and eGFR of 30 mL/min/1.73m2 or higher
- Proteinuria of at least 0.8 g/g or 1 g/day measured at screening
- Baseline biopsy showing less than 50% tubulointerstitial fibrosis
- On stable ACE inhibitor or ARB treatment at maximal or tolerated dose for about 90 days before baseline and continuing throughout the study
- Stable doses of diuretics, other antihypertensive medications, or SGLT2 inhibitors for at least 90 days prior to baseline
- Completed vaccinations against Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks before treatment start; if not previously vaccinated, vaccination or prophylactic antibiotics as per protocol
- Vaccination against Haemophilus influenzae at least 2 weeks before treatment if available and per local regulations
You will not qualify if you...
- Secondary IgA nephropathy or IgA vasculitis Henoch-Scholein Purpura
- Any other secondary diagnosis in baseline biopsy apart from IgA nephropathy
- Significant urinary obstruction or other urinary tract disorders apart from IgAN
- Use of homeopathic or herbal medications for IgAN progression
- Acute kidney injury within 4 weeks prior to screening
- Rapidly progressive glomerulonephritis or nephrotic syndrome
- Sitting office systolic blood pressure over 140 mmHg or diastolic over 90 mmHg at screening
- Use of immunosuppressive or immunomodulatory drugs within 90 days (or 180 days for rituximab) before treatment start
- Use of other investigational drugs within 5 half-lives or 30 days prior to enrollment
- Prior use of iptacopan or participation in an iptacopan trial
- History of any solid organ or bone marrow transplantation
- History of recurrent invasive infections with encapsulated organisms
- Major comorbidities like advanced cardiac, severe pulmonary, or hepatic disease
- Any medical condition interfering with study participation or requiring prohibited medications
- Active systemic bacterial, viral (including COVID-19), or fungal infection within 14 days before treatment
- Fever of 38°C (100.4°F) or higher within 7 days before treatment
- HIV infection or positive HIV antibody test at screening
- Hypersensitivity to study drugs or similar compounds
- Liver disease including active hepatitis B or C or abnormal liver function tests exceeding defined limits
- History of malignancy within past 5 years except certain skin or cervical cancers
- Pregnant or nursing women
- Women of childbearing potential not agreeing to use effective contraception during and 1 week after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
Central Florida Kidney Specialists
Orlando, Florida, United States, 32806
Actively Recruiting
4
Georgia Nephrology Research Inst
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
5
CaRe Research
Chubbuck, Idaho, United States, 83202
Actively Recruiting
6
DaVita Clinical Research
Las Vegas, Nevada, United States, 89146
Actively Recruiting
7
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
8
OSU Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
10
Novartis Investigative Site
CABA, Buenos Aires, Argentina, 1280
Actively Recruiting
11
Novartis Investigative Site
CABA, Buenos Aires, Argentina, 1425
Actively Recruiting
12
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina, 5000
Actively Recruiting
13
Novartis Investigative Site
Ashdod, Israel, 7747629
Actively Recruiting
14
Novartis Investigative Site
Hadera, Israel, 3820302
Actively Recruiting
15
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
16
Novartis Investigative Site
Nahariya, Israel, 2210001
Actively Recruiting
17
Novartis Investigative Site
Kuala Lumpur, Selangor, Malaysia, 43000
Actively Recruiting
18
Novartis Investigative Site
Riyadh, Saudi Arabia, 11211
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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