Actively Recruiting
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
Led by Novartis Pharmaceuticals · Updated on 2026-04-01
31
Participants Needed
15
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A nephropathy (IgAN) pediatric patients aged 2 to \<18 years.
CONDITIONS
Official Title
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female children aged 2 to less than 18 years on Day 1
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73m2 at Screening and confirmed during Run-in
- Primary IgAN confirmed by kidney biopsy performed within 3 years of Screening showing less than 50% tubulointerstitial fibrosis and less than 25% crescents
- Minimum body weight of 35 kg for participants aged 12 to less than 18 years at Screening and Baseline
- Proteinuria (UPCR) of at least 1 g/g measured from first morning urine samples at specified visits despite stable ACE inhibitor/ARB treatment for at least 120 days
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae before starting treatment; Haemophilus influenzae vaccination recommended
- Stable dose of ACE inhibitor or ARB and other IgAN background medications for at least 120 days before first study drug administration
You will not qualify if you...
- Secondary IgAN or immunoglobulin A vasculitis (IgAV) diagnosis
- Significant urinary obstruction, other chronic kidney diseases, or current acute kidney injury
- Rapidly progressive glomerulonephritis or nephrotic syndrome
- Significant ECG or echocardiogram abnormalities indicating cardiac risk
- Abnormal blood pressure or pulse rate outside specified ranges for age groups
- Prior immunosuppressive or immunomodulatory treatments within 120 days (or 180 days for rituximab)
- Any solid organ transplantation
- History of recurrent invasive infections from encapsulated organisms
- Major concurrent serious health conditions such as advanced cardiac, pulmonary, or liver disease
- Current use of homeopathic or herbal medications for IgAN such as Lei Gong Teng
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399
Actively Recruiting
3
Prim Childrens Hosp Inv Pharm
Salt Lake City, Utah, United States, 84113
Actively Recruiting
4
Novartis Investigative Site
Brisbane, Queensland, Australia, 4101
Actively Recruiting
5
Novartis Investigative Site
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
6
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
7
Novartis Investigative Site
Beijing, China, 100034
Actively Recruiting
8
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
9
Novartis Investigative Site
Beersheba, Israel, 8457108
Actively Recruiting
10
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
11
Novartis Investigative Site
Jerusalem, Israel, 9103102
Actively Recruiting
12
Novartis Investigative Site
Petah Tikva, Israel, 4920235
Actively Recruiting
13
Novartis Investigative Site
Kurume, Fukuoka, Japan, 830-0011
Actively Recruiting
14
Novartis Investigative Site
Ohtsu, Shiga, Japan, 5202192
Actively Recruiting
15
Novartis Investigative Site
Fuchū, Tokyo, Japan, 1838561
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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