Actively Recruiting

Phase 3
Age: 12Years - 100Years
All Genders
NCT03955445

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

Led by Novartis Pharmaceuticals · Updated on 2026-04-14

225

Participants Needed

50

Research Sites

869 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis

CONDITIONS

Official Title

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

Who Can Participate

Age: 12Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
Not Eligible

You will not qualify if you...

  • Severe concurrent co-morbidities such as advanced cardiac disease (NYHA class IV) or severe pulmonary arterial hypertension (WHO class IV) that may prevent safe study participation
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to screening or fever ≥ 38°C (100.4°F) within 7 days prior to screening
  • History or current diagnosis of ECG abnormalities that pose significant safety risks
  • History of HIV or any other immunodeficiency disease
  • Any illness or medical condition that investigator and sponsor believe may prevent safe tolerability or compliance with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 50 locations

1

Childrens Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Georgia Nephrology Research Inst

Lawrenceville, Georgia, United States, 30046

Actively Recruiting

3

University of Iowa Health Care

Iowa City, Iowa, United States, 52242-1091

Actively Recruiting

4

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

5

Col Uni Med Center New York Presby

New York, New York, United States, 10032

Actively Recruiting

6

Novartis Investigative Site

CABA, Buenos Aires, Argentina, C1425AGC

Actively Recruiting

7

Novartis Investigative Site

Buenos Aires, Argentina, W3400ABH

Actively Recruiting

8

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil, 30150-221

Actively Recruiting

9

Novartis Investigative Site

Recife, Pernambuco, Brazil, 50740-900

Actively Recruiting

10

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil, 90035-074

Actively Recruiting

11

Novartis Investigative Site

Botucatu, São Paulo, Brazil, 3880-1001

Actively Recruiting

12

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 04038-002

Actively Recruiting

13

Novartis Investigative Site

Salvador, Brazil, 40323-010

Actively Recruiting

14

Novartis Investigative Site

Toronto, Ontario, Canada, M5G 2C4

Active, Not Recruiting

15

Novartis Investigative Site

Beijing, China, 100034

Actively Recruiting

16

Novartis Investigative Site

Shanghai, China, 200040

Actively Recruiting

17

Novartis Investigative Site

Prague, Czechia, 128 08

Active, Not Recruiting

18

Novartis Investigative Site

Montpellier, France, 34295

Actively Recruiting

19

Novartis Investigative Site

Paris, France, 75015

Actively Recruiting

20

Novartis Investigative Site

Toulouse, France, 31054

Actively Recruiting

21

Novartis Investigative Site

Erlangen, Germany, 91054

Active, Not Recruiting

22

Novartis Investigative Site

Essen, Germany, 45147

Actively Recruiting

23

Novartis Investigative Site

Hamburg, Germany, 20246

Actively Recruiting

24

Novartis Investigative Site

Mainz, Germany, 55131

Actively Recruiting

25

Novartis Investigative Site

Heraklion Crete., Greece, 715 00

Actively Recruiting

26

Novartis Investigative Site

Thessaloniki, Greece, 546 42

Actively Recruiting

27

Novartis Investigative Site

Petah Tikva, Israel, 4920235

Actively Recruiting

28

Novartis Investigative Site

Petah Tikva, Israel, 4941492

Actively Recruiting

29

Novartis Investigative Site

Ranica, BG, Italy, 24020

Actively Recruiting

30

Novartis Investigative Site

Roma, Italy, 165

Actively Recruiting

31

Novartis Investigative Site

Nagoya, Aichi-ken, Japan, 4668560

Active, Not Recruiting

32

Novartis Investigative Site

Asahikawa, Hokkaido, Japan, 0788510

Active, Not Recruiting

33

Novartis Investigative Site

Sapporo, Hokkaido, Japan, 0608543

Completed

34

Novartis Investigative Site

Takatsuki, Osaka, Japan, 5691192

Active, Not Recruiting

35

Novartis Investigative Site

Ohtsu, Shiga, Japan, 5202192

Actively Recruiting

36

Novartis Investigative Site

Hachiōji, Tokyo, Japan, 193-0998

Actively Recruiting

37

Novartis Investigative Site

Niigata, Japan, 9518520

Active, Not Recruiting

38

Novartis Investigative Site

Leiden, South Holland, Netherlands, 2333 ZA

Actively Recruiting

39

Novartis Investigative Site

Pamplona, Navarre, Spain, 31008

Actively Recruiting

40

Novartis Investigative Site

Barcelona, Spain, 08035

Active, Not Recruiting

41

Novartis Investigative Site

Madrid, Spain, 28040

Actively Recruiting

42

Novartis Investigative Site

Madrid, Spain, 28041

Actively Recruiting

43

Novartis Investigative Site

Seville, Spain, 41009

Actively Recruiting

44

Novartis Investigative Site

Bern, Switzerland, 3010

Actively Recruiting

45

Novartis Investigative Site

Köseköy, Kocaeli, Turkey (Türkiye), 41380

Actively Recruiting

46

Novartis Investigative Site

Kayseri, Melikgazi, Turkey (Türkiye), 38039

Actively Recruiting

47

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye), 06500

Actively Recruiting

48

Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN

Actively Recruiting

49

Novartis Investigative Site

Cardiff, United Kingdom, CF14 4XW

Actively Recruiting

50

Novartis Investigative Site

London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

6

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