Actively Recruiting
A Multicenter, Single Arm, Open Label Biopsy Study to Evaluate Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy Receiving Iptacopan on Top of Supportive Care
Led by Novartis Pharmaceuticals · Updated on 2026-04-27
20
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of iptacopan treatment on the immune-related processes in adults with Immunoglobulin A Nephropathy (IgAN). The study focuses on changes in important clinical and molecular markers, including kidney tissue changes and kidney function indicators, over a 9-month period. It also examines complement activation and multiple biomarkers related to kidney damage and disease progression. Participants will undergo a screening period and a baseline visit, during which a kidney biopsy will be performed. Eligible adults with IgAN will receive iptacopan 200 mg twice daily orally for 9 months, alongside their usual stable doses of ACE inhibitors or angiotensin receptor blockers. At the end of the treatment period, a follow-up kidney biopsy will be done to assess changes in the kidney structure. Throughout the study, participants will be monitored via kidney biopsies, clinical assessments, and biomarker measurements. The main outcome is the reduction in complement C3c deposits in the kidney after 9 months. Secondary outcomes include changes in immune cell markers and immunoglobulin staining. Safety and adherence will be observed during the treatment period, with the total participation lasting about 9 months from baseline to study end.
CONDITIONS
Brief 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 ability to communicate and comply with study requirements
- Male and female adults aged 18 years or older with biopsy-confirmed IgA nephropathy
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73m2 or higher
- Proteinuria with urine protein-to-creatinine ratio (UPCR) of 0.8 g/g or higher or 1 g/day or higher
- Baseline kidney biopsy showing less than 50% tubulointerstitial fibrosis
- On stable, maximally tolerated or approved doses of ACE inhibitors or angiotensin receptor blockers for approximately 90 days prior to baseline and throughout the study
- Required vaccinations against Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks before treatment
- Vaccination against Haemophilus influenzae if available, at least 2 weeks before treatment
You will not qualify if you...
- Secondary IgA nephropathy or IgA vasculitis Henoch-Scholein Purpura
- Other kidney diseases diagnosed at baseline biopsy
- Significant urinary obstruction or voiding difficulties
- Use of homeopathic or herbal medications for IgAN progression
- Acute kidney injury within 4 weeks prior to screening
- Rapidly progressive glomerulonephritis or nephrotic syndrome
- High blood pressure (systolic >140 mmHg or diastolic >90 mmHg) at screening
- Recent use of immunosuppressive or immunomodulatory drugs within specified time frames
- Use of other investigational drugs within 5 half-lives or 30 days before enrollment
- Prior use of iptacopan or participation in iptacopan trials
- History of any organ transplantation
- Recurrent invasive infections by encapsulated organisms
- Major concurrent severe medical conditions
- Active infections or fever prior to study drug administration
- Known HIV infection
- Hypersensitivity to study drugs or similar compounds
- Active liver disease or abnormal liver function tests
- Recent history of malignancy within 5 years, except certain treated skin or cervical cancers
- Pregnant or nursing women
- Women of childbearing potential not using effective contraception during and shortly after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants attend a baseline visit where a kidney biopsy is performed to assess initial structural and functional kidney status.
1 baseline visit (in-person)
Duration - 9 months
Participants receive iptacopan 200 mg twice daily along with their standard supportive care for IgA nephropathy over a 9-month period.
Duration - 1 day
At the end of the 9-month treatment period, participants undergo a follow-up kidney biopsy to evaluate changes from baseline.
1 visit (in-person)
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
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here