Actively Recruiting

Phase 3
Age: 12Years - 60Years
All Genders
NCT05755386

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

Led by Novartis Pharmaceuticals · Updated on 2026-04-29

106

Participants Needed

127

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

CONDITIONS

Official Title

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

Who Can Participate

Age: 12Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 12 to 60 years (adolescents 12-17 years in non-EU, 16-17 years in EU countries)
  • Diagnosis of idiopathic IC-MPGN confirmed by kidney biopsy within 12 months for adults or 3 years for adolescents
  • On a stable, maximally tolerated dose of renin angiotensin system inhibitors or other proteinuria control drugs for at least 90 days prior to randomization
  • Urine protein-to-creatinine ratio (UPCR) 2 1.0 g/g from first morning urine samples
  • Estimated or measured glomerular filtration rate (GFR) 2 30 ml/min/1.73m2 at screening
  • Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae before treatment start
  • Vaccinated against Haemophilus influenzae if applicable and according to local regulations
Not Eligible

You will not qualify if you...

  • History of cell or solid organ transplantation including kidney transplant
  • Secondary IC-MPGN caused by chronic infections (e.g., hepatitis B or C, bacterial infections, protozoa)
  • IC-MPGN due to systemic autoimmune diseases (e.g., lupus, Sj�f6gren syndrome, rheumatoid arthritis)
  • Monoclonal gammopathy or fibrillary glomerulonephritis
  • Rapidly progressive crescentic glomerulonephritis or kidney biopsy showing >50% interstitial fibrosis/tubular atrophy
  • Active bacterial, viral, or fungal infection within 14 days or fever 2 38�b0C within 7 days before treatment
  • History of recurrent invasive infections from encapsulated organisms
  • Use of complement inhibitors within 3 months or 5 half-lives before screening
  • Use of immunosuppressants (except mycophenolic acids), high-dose corticosteroids, or cyclophosphamide within 90 days before treatment
  • Use of mycophenolic acids prohibited within 90 days before randomization in India
  • Acute post-infectious glomerulonephritis at screening
  • Body mass index (BMI) >38 kg/m2 or body weight <35 kg at screening and randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 127 locations

1

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

2

Univ Cali Irvine ALS Neuromuscular

Orange, California, United States, 92868

Actively Recruiting

3

UCSF

San Francisco, California, United States, 94115

Actively Recruiting

4

Olive View UCLA Medical Center

Sylmar, California, United States, 91342

Actively Recruiting

5

Childrens Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

6

Nicklaus Childrens Hospital

Miami, Florida, United States, 33155

Actively Recruiting

7

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

8

Boston Univ School of Medicine

Boston, Massachusetts, United States, 02118

Actively Recruiting

9

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

10

Washington University in St Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

11

University of New Mexico

Albuquerque, New Mexico, United States, 87131-0001

Actively Recruiting

12

Col Uni Med Center New York Presby

New York, New York, United States, 10032

Actively Recruiting

13

University Of Cincinnati

Cincinnati, Ohio, United States, 45267

Actively Recruiting

14

OHSU Dept of Nephrology

Portland, Oregon, United States, 97239

Actively Recruiting

15

Univ of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

16

MUSC Health Lancaster Med Ctr

Lancaster, South Carolina, United States, 29720

Actively Recruiting

17

UT Southwestern Medical Center

Dallas, Texas, United States, 75235

Actively Recruiting

18

Prolato Clinical Research Center

Houston, Texas, United States, 77054

Actively Recruiting

19

Baylor Scott and White Research

Temple, Texas, United States, 76502

Actively Recruiting

20

University of Utah

Salt Lake City, Utah, United States, 84113

Actively Recruiting

21

University of Wisconsin

Madison, Wisconsin, United States, 53792

Actively Recruiting

22

Novartis Investigative Site

CABA, Buenos Aires, Argentina, C1425AGC

Actively Recruiting

23

Novartis Investigative Site

CABA, Buenos Aires, Argentina, C1425EFD

Actively Recruiting

24

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina, X5000

Actively Recruiting

25

Novartis Investigative Site

Buenos Aires, Argentina, W3400ABH

Actively Recruiting

26

Novartis Investigative Site

CABA, Argentina, C1181ACH

Actively Recruiting

27

Novartis Investigative Site

Santa Fe, Argentina, S3000EPV

Actively Recruiting

28

Novartis Investigative Site

Fortaleza, Ceará, Brazil, 60430 370

Actively Recruiting

29

Novartis Investigative Site

Brasília, Federal District, Brazil, 71635-580

Withdrawn

30

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil, 30150-221

Actively Recruiting

31

Novartis Investigative Site

Recife, Pernambuco, Brazil, 50740-900

Actively Recruiting

32

Novartis Investigative Site

Niterói, Rio de Janeiro, Brazil, 24020 096

Withdrawn

33

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil, 22211-230

Withdrawn

34

Novartis Investigative Site

Natal, Rio Grande do Norte, Brazil, 59012 300

Actively Recruiting

35

Novartis Investigative Site

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

Actively Recruiting

36

Novartis Investigative Site

Botucatu, São Paulo, Brazil, 18618-970

Actively Recruiting

37

Novartis Investigative Site

Santo André, São Paulo, Brazil, 09090-790

Actively Recruiting

38

Novartis Investigative Site

Sao Jose Rio Preto, São Paulo, Brazil, 15090-000

Actively Recruiting

39

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 04038-002

Actively Recruiting

40

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 05403 000

Withdrawn

41

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 05403-000

Actively Recruiting

42

Novartis Investigative Site

Salvador, Brazil, 40323-010

Actively Recruiting

43

Novartis Investigative Site

Etobicoke, Ontario, Canada, M9W 6V1

Actively Recruiting

44

Novartis Investigative Site

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

45

Novartis Investigative Site

Montreal, Quebec, Canada, H2X 1R9

Actively Recruiting

46

Novartis Investigative Site

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

47

Novartis Investigative Site

Prague, Czechia, 128 08

Actively Recruiting

48

Novartis Investigative Site

Aarhus N, Denmark, 8200

Actively Recruiting

49

Novartis Investigative Site

Copenhagen, Denmark, DK-2100

Actively Recruiting

50

Novartis Investigative Site

Marseille, France, 13005

Actively Recruiting

51

Novartis Investigative Site

Montpellier, France, 34295

Actively Recruiting

52

Novartis Investigative Site

Paris, France, 75015

Actively Recruiting

53

Novartis Investigative Site

Rennes, France, 35033

Actively Recruiting

54

Novartis Investigative Site

Toulouse, France, 31054

Actively Recruiting

55

Novartis Investigative Site

Munich, Bavaria, Germany, 81377

Actively Recruiting

56

Novartis Investigative Site

Würzburg, Bavaria, Germany, 97080

Actively Recruiting

57

Novartis Investigative Site

Dresden, Saxony, Germany, 01307

Actively Recruiting

58

Novartis Investigative Site

Jena, Thuringia, Germany, 07740

Actively Recruiting

59

Novartis Investigative Site

Berlin, Germany, 13353

Actively Recruiting

60

Novartis Investigative Site

Essen, Germany, 45147

Actively Recruiting

61

Novartis Investigative Site

Hamburg, Germany, 20246

Actively Recruiting

62

Novartis Investigative Site

Hanover, Germany, 30625

Actively Recruiting

63

Novartis Investigative Site

Mainz, Germany, 55131

Actively Recruiting

64

Novartis Investigative Site

Ulm, Germany, 89081

Actively Recruiting

65

Novartis Investigative Site

Athens, Greece, 115 27

Actively Recruiting

66

Novartis Investigative Site

Chaïdári, Greece, 124 62

Actively Recruiting

67

Novartis Investigative Site

Heraklion Crete., Greece, 715 00

Actively Recruiting

68

Novartis Investigative Site

Ioannina, Greece, 455 00

Actively Recruiting

69

Novartis Investigative Site

Pátrai, Greece, 265 04

Actively Recruiting

70

Novartis Investigative Site

Thessaloniki, Greece, 54636

Actively Recruiting

71

Novartis Investigative Site

Thessaloniki, Greece, 570 10

Actively Recruiting

72

Novartis Investigative Site

Bangalore, Karnataka, India, 560004

Actively Recruiting

73

Novartis Investigative Site

Nagpur, Maharashtra, India, 440015

Actively Recruiting

74

Novartis Investigative Site

Pune, Maharashtra, India, 411011

Actively Recruiting

75

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

76

Novartis Investigative Site

Hyderabad, Telangana, India, 500082

Actively Recruiting

77

Novartis Investigative Site

Haifa, Israel, 3109601

Actively Recruiting

78

Novartis Investigative Site

Jerusalem, Israel, 9103102

Actively Recruiting

79

Novartis Investigative Site

Petah Tikva, Israel, 4920235

Actively Recruiting

80

Novartis Investigative Site

Bari, BA, Italy, 70124

Actively Recruiting

81

Novartis Investigative Site

Ranica, BG, Italy, 24020

Actively Recruiting

82

Novartis Investigative Site

Brescia, BS, Italy, 25123

Actively Recruiting

83

Novartis Investigative Site

Milan, MI, Italy, 20122

Actively Recruiting

84

Novartis Investigative Site

Roma, RM, Italy, 00165

Actively Recruiting

85

Novartis Investigative Site

Torino, TO, Italy, 10126

Actively Recruiting

86

Novartis Investigative Site

Naples, Italy, 80131

Actively Recruiting

87

Novartis Investigative Site

Fuchū, Tokyo, Japan, 1838561

Actively Recruiting

88

Novartis Investigative Site

Hachiōji, Tokyo, Japan, 193-0998

Actively Recruiting

89

Novartis Investigative Site

Okayama, Japan, 7008558

Actively Recruiting

90

Novartis Investigative Site

Osaka, Japan, 558-8558

Actively Recruiting

91

Novartis Investigative Site

Groningen, Netherlands, 9713 GZ

Actively Recruiting

92

Novartis Investigative Site

Poznan, Greater Poland Voivodeship, Poland, 60-355

Actively Recruiting

93

Novartis Investigative Site

Bialystok, Poland, 15-540

Actively Recruiting

94

Novartis Investigative Site

Krakow, Poland, 30-688

Actively Recruiting

95

Novartis Investigative Site

Olsztyn, Poland, 10-561

Actively Recruiting

96

Novartis Investigative Site

Warsaw, Poland, 02-006

Actively Recruiting

97

Novartis Investigative Site

Warsaw, Poland, 02-097

Actively Recruiting

98

Novartis Investigative Site

Wroclaw, Poland, 50-417

Withdrawn

99

Novartis Investigative Site

Martin, Slovakia, Slovakia, 036 59

Actively Recruiting

100

Novartis Investigative Site

Košice, Slovakia, 041 90

Actively Recruiting

101

Novartis Investigative Site

Seoul, Seoul, South Korea, 03080

Actively Recruiting

102

Novartis Investigative Site

Seoul, South Korea, 03722

Actively Recruiting

103

Novartis Investigative Site

Pamplona, Navarre, Spain, 31008

Actively Recruiting

104

Novartis Investigative Site

Almería, Spain, 04009

Actively Recruiting

105

Novartis Investigative Site

Barcelona, Spain, 08035

Actively Recruiting

106

Novartis Investigative Site

Barcelona, Spain, 08036

Actively Recruiting

107

Novartis Investigative Site

Madrid, Spain, 28040

Actively Recruiting

108

Novartis Investigative Site

Madrid, Spain, 28041

Actively Recruiting

109

Novartis Investigative Site

Madrid, Spain, 280796

Actively Recruiting

110

Novartis Investigative Site

Salamanca, Spain, 37007

Actively Recruiting

111

Novartis Investigative Site

Bern, Switzerland, 3010

Actively Recruiting

112

Novartis Investigative Site

Lausanne, Switzerland, 1011

Actively Recruiting

113

Novartis Investigative Site

Zurich, Switzerland, 8091

Actively Recruiting

114

Novartis Investigative Site

Kaohsiung City, Taiwan, 81346

Actively Recruiting

115

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye), 34093

Actively Recruiting

116

Novartis Investigative Site

Izmir, Karsiyaka, Turkey (Türkiye), 35575

Actively Recruiting

117

Novartis Investigative Site

Köseköy, Kocaeli, Turkey (Türkiye), 41380

Actively Recruiting

118

Novartis Investigative Site

Kayseri, Melikgazi, Turkey (Türkiye), 38039

Actively Recruiting

119

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye), 06500

Actively Recruiting

120

Novartis Investigative Site

Mersin, Yenisehir, Turkey (Türkiye), 33110

Actively Recruiting

121

Novartis Investigative Site

Belfast, United Kingdom, BT9 7AB

Actively Recruiting

122

Novartis Investigative Site

Cardiff, United Kingdom, CF14 4XW

Actively Recruiting

123

Novartis Investigative Site

London, United Kingdom, NW3 2QG

Actively Recruiting

124

Novartis Investigative Site

London, United Kingdom, WC1N 3JH

Actively Recruiting

125

Novartis Investigative Site

Manchester, United Kingdom, M13 9WL

Actively Recruiting

126

Novartis Investigative Site

Salford, United Kingdom, M6 8HD

Actively Recruiting

127

Novartis Investigative Site

Ho Chi Minh City, Vietnam, 700000

Actively Recruiting

Loading map...

Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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