Actively Recruiting
Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Led by Novartis Pharmaceuticals · Updated on 2026-04-29
50
Participants Needed
31
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.
CONDITIONS
Official Title
Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults 18 years of age or older diagnosed with aHUS, excluding other types of thrombotic microangiopathy and non-aHUS kidney diseases
- Currently receiving recommended dose of anti-C5 antibody treatment for at least 3 months before screening
- Investigator's opinion that participant has responded to anti-C5 antibody treatment with clinical evidence during screening
- Clinical response confirmed by hematological normalization (platelet count ≥150 x 10^9/L and LDH below upper limit of normal) and stable kidney function (serum creatinine within ±15% during screening)
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae before starting iptacopan
- Vaccination against Haemophilus influenzae if not previously given or if booster is needed, according to local regulations
You will not qualify if you...
- History of aHUS relapse while on anti-C5 antibody treatment
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m²
- Active infection or history of recurrent serious infections caused by encapsulated bacteria such as meningococcus, pneumococcus, or Haemophilus influenzae
- Sepsis or active systemic bacterial, viral (including COVID-19), or fungal infection within 14 days before starting study treatment
- History of any organ or stem cell transplant including kidney, bone marrow, heart, lung, small bowel, pancreas, or liver
- Female participants who are pregnant, breastfeeding, or planning to conceive during the study
- Any medical condition that might interfere with participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Novartis Investigative Site
Nanjing, Jiangsu, China, 210009
Withdrawn
2
Novartis Investigative Site
Beijing, China, 100034
Active, Not Recruiting
3
Novartis Investigative Site
Beijing, China, 100730
Active, Not Recruiting
4
Novartis Investigative Site
Shanghai, China, 200025
Withdrawn
5
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
6
Novartis Investigative Site
Paris, France, 75015
Actively Recruiting
7
Novartis Investigative Site
Paris, France, 75970
Actively Recruiting
8
Novartis Investigative Site
Rouen, France, 76031
Actively Recruiting
9
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
10
Novartis Investigative Site
Tours, France, 37044
Actively Recruiting
11
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
12
Novartis Investigative Site
Kiel, Germany, 24105
Actively Recruiting
13
Novartis Investigative Site
Ranica, BG, Italy, 24020
Actively Recruiting
14
Novartis Investigative Site
Milan, MI, Italy, 20122
Actively Recruiting
15
Novartis Investigative Site
Roma, RM, Italy, 00168
Actively Recruiting
16
Novartis Investigative Site
Matsumoto-shi, Nagano, Japan, 3908510
Actively Recruiting
17
Novartis Investigative Site
Iruma-gun, Saitama, Japan, 3500495
Actively Recruiting
18
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 113-8655
Actively Recruiting
19
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
20
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
21
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
22
Novartis Investigative Site
Málaga, Spain, 29010
Actively Recruiting
23
Novartis Investigative Site
Seville, Spain, 41013
Actively Recruiting
24
Novartis Investigative Site
Valencia, Spain, 46026
Actively Recruiting
25
Novartis Investigative Site
Izmir, Balcova, Turkey (Türkiye), 35340
Withdrawn
26
Novartis Investigative Site
Köseköy, Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
27
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Actively Recruiting
28
Novartis Investigative Site
Mersin, Yenisehir, Turkey (Türkiye), 33110
Actively Recruiting
29
Novartis Investigative Site
Glasgow, Scotland, United Kingdom, G51 4TF
Actively Recruiting
30
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Actively Recruiting
31
Novartis Investigative Site
London, United Kingdom, NW1 2BU
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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