Actively Recruiting

Phase 2
Age: 12Years +
All Genders
NCT07355296

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Led by Boehringer Ingelheim · Updated on 2026-05-13

132

Participants Needed

148

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

CONDITIONS

Official Title

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants 18 years or older (12 years or older for treatment-resistant primary Minimal Change Disease) at consent
  • Body Mass Index of 40 kg/m2 or less at screening
  • Weight of 40 kg or more at screening
  • Estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73 m2 or higher at screening
  • Seated systolic blood pressure 160 mmHg or lower for adults (18 or older) or 140 mmHg or lower for participants under 18 at screening
  • Stable treatment with angiotensin converting enzyme inhibitors or angiotensin receptor blockers for at least 8 weeks before screening, with no planned dose changes during treatment unless not tolerated
  • Stable doses of mineralocorticoid receptor antagonists, endothelin receptor antagonists, GLP-1 or SGLT2 inhibitors for at least 8 weeks before screening, preferably with no planned changes
  • Stable oral immunosuppressive therapy (except glucocorticoids) for at least 12 weeks before screening with no planned dose changes
  • If on oral glucocorticoids, dose must be 10 mg/day prednisolone or less for at least 4 weeks before screening with no planned increases during treatment
Not Eligible

You will not qualify if you...

  • History of organ transplantation or planned transplantation during the study
  • Use of intravenous immunosuppressive agents within 6 months before screening
  • Anticipated start of oral or intravenous immunosuppression during the trial
  • Treatment with metformin or dofetilide within one week before randomization through 5 days after end of treatment
  • Use of strong inhibitors or inducers of cytochrome P450 3A4/5 within one week or 5 half-lives before randomization
  • Alanine aminotransferase or aspartate aminotransferase levels more than 3 times the upper limit of normal at screening
  • Clinically significant lab abnormalities or medical conditions posing safety risks or interfering with trial objectives
  • QTc intervals greater than 450 ms in males or 470 ms in females, or other relevant ECG findings at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 148 locations

1

Nephrology Consultants, LLC

Huntsville, Alabama, United States, 35805

Not Yet Recruiting

2

Kidney Disease Medical Group

Glendale, California, United States, 91206

Not Yet Recruiting

3

Amicis Research Center - Balboa

Granada Hills, California, United States, 91344

Not Yet Recruiting

4

Academic Medical Research Institute - Glendale

Los Angeles, California, United States, 90022

Not Yet Recruiting

5

University of California Los Angeles

Los Angeles, California, United States, 90095

Not Yet Recruiting

6

Colorado Kidney Center

Denver, Colorado, United States, 80220

Not Yet Recruiting

7

Florida Kidney Physicians - Boca Raton

Boca Raton, Florida, United States, 33487

Not Yet Recruiting

8

Florida Kidney Physicians, LLC - Fort Lauderdale

Fort Lauderdale, Florida, United States, 33316

Not Yet Recruiting

9

Total Research Group, LLC

Miami, Florida, United States, 33126

Not Yet Recruiting

10

CTR Oakwater, LLC

Orlando, Florida, United States, 32806

Not Yet Recruiting

11

Panoramic Health

Riverview, Florida, United States, 33578

Not Yet Recruiting

12

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Not Yet Recruiting

13

Endeavor Health

Evanston, Illinois, United States, 60201

Not Yet Recruiting

14

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Not Yet Recruiting

15

St. Clair Nephrology Research, LLC - Shelby Township

Shelby, Michigan, United States, 48315

Not Yet Recruiting

16

New York Nephrology and Dialysis Access Surgery, PC

Clifton Park, New York, United States, 12065

Not Yet Recruiting

17

NYU Langone Nephrology Associates-Mineola

Mineola, New York, United States, 11501

Not Yet Recruiting

18

Duke University Medical Center

Durham, North Carolina, United States, 27710

Not Yet Recruiting

19

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

20

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Not Yet Recruiting

21

Northeast Clinical Research Center

Bethlehem, Pennsylvania, United States, 18017

Not Yet Recruiting

22

Southeast Renal Research Institute

Chattanooga, Tennessee, United States, 37404

Not Yet Recruiting

23

Nephrotex Research Group

Dallas, Texas, United States, 75231

Not Yet Recruiting

24

Provecta Researh Network

Houston, Texas, United States, 77027

Not Yet Recruiting

25

West Virginia University Medicine

Morgantown, West Virginia, United States, 26506

Not Yet Recruiting

26

Centro Medico Dra Laura Maffei

Ciudad Autonoma Buenos Aires, Argentina, C1425AGC

Not Yet Recruiting

27

Clinica Privada Velez Sarfield

Córdoba, Argentina, 5000

Not Yet Recruiting

28

CardioAlem Investigaciones

San Isidro, Argentina, B1642DCD

Not Yet Recruiting

29

Nepean Hospital

Kingswood, New South Wales, Australia, 2747

Not Yet Recruiting

30

John Hunter Hospital

New Lambton Heights, New South Wales, Australia, 2305

Not Yet Recruiting

31

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia, 4029

Not Yet Recruiting

32

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Not Yet Recruiting

33

AZORG Ziekenhuis

Aalst, Belgium, 9300

Not Yet Recruiting

34

ULB Hopital Erasme

Brussels, Belgium, 1070

Not Yet Recruiting

35

Az Maria Middelares Gent

Ghent, Belgium, 9000

Not Yet Recruiting

36

UZ Leuven

Leuven, Belgium, 3000

Not Yet Recruiting

37

Universidade Federal do Ceará

Fortaleza, Brazil, 60110-110

Not Yet Recruiting

38

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil, 90035-903

Not Yet Recruiting

39

Fundação Oswaldo Ramos (Hospital do Rim)

São Paulo, Brazil, 04038-002

Actively Recruiting

40

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, Brazil, 05403-000

Not Yet Recruiting

41

Instituto da Criança e do Adolescente

São Paulo, Brazil, 05403-901

Not Yet Recruiting

42

CaRe Clinic (Calgary)

Calgary, Alberta, Canada, T2N 4L7

Not Yet Recruiting

43

Victoria Hospital (LHSC)

London, Ontario, Canada, N6A 5W9

Not Yet Recruiting

44

Maisonneuve-Rosemont Hospital

Monteral, Quebec, Canada, H1T 2M4

Not Yet Recruiting

45

Peking University First Hospital

Beijing, China, 100034

Not Yet Recruiting

46

Beijing Tsinghua Changgung Hospital

Beijing, China, 100044

Not Yet Recruiting

47

West China Hospital, Sichuan University

Chengdu, China, 610041

Not Yet Recruiting

48

Guangdong Provincial People's Hospital

Guangzhou, China, 510080

Not Yet Recruiting

49

The First Affiliated Hospital of Nanchang University

Nanchang, China, 330006

Not Yet Recruiting

50

Zhongda Hospital Southeast University

Nanjing, China, 210009

Not Yet Recruiting

51

The First People's Hospital of Nanning

Nanning, China, 530000

Not Yet Recruiting

52

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200025

Not Yet Recruiting

53

Shanghai General Hospital

Shanghai, China, 200080

Not Yet Recruiting

54

People's Hospital of Sichuan Province

Sichuan, China, 610031

Not Yet Recruiting

55

Renmin Hospital of Wuhan University

Wuhan, China, 430060

Not Yet Recruiting

56

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, China, 361004

Not Yet Recruiting

57

Specijalna Bolnica Medico

Rijeka, Croatia, 51000

Not Yet Recruiting

58

General Hospital Vinkovci

Vinkovci, Croatia, 32100

Not Yet Recruiting

59

Clinical Hospital Sveti Duh

Zagreb, Croatia, 10000

Not Yet Recruiting

60

Solmed Polyclinic

Zagreb, Croatia, 10000

Not Yet Recruiting

61

University Hospital Dubrava

Zagreb, Croatia, 10000

Not Yet Recruiting

62

Zealand University Hospita; Roskilde

Roskilde, Denmark, 4000

Not Yet Recruiting

63

Tartu University Hospital

Tartu, Estonia, 51014

Not Yet Recruiting

64

CHU Amiens-Picardie

Amiens, France, 80054

Not Yet Recruiting

65

HOP Pellegrin

Bordeaux, France, 33076

Not Yet Recruiting

66

Hôpital Henri Mondor

Créteil, France, 94000

Not Yet Recruiting

67

Hôpital Pasteur

Nice, France, 06000

Not Yet Recruiting

68

Hôpital Necker

Paris, France, 75015

Not Yet Recruiting

69

Vivantes Klinikum im Friedrichshain

Berlin, Germany, 10249

Not Yet Recruiting

70

Universitätsklinikum Köln (AöR)

Cologne, Germany, 50937

Not Yet Recruiting

71

Universitätsklinikum Hamburg, Eppendorf

Hamburg, Germany, 20246

Not Yet Recruiting

72

Medizinische Hochschule Hannover

Hanover, Germany, 30625

Not Yet Recruiting

73

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany, 55131

Not Yet Recruiting

74

University General Hospital of Heraklion

Heraklion, Greece, 71500

Not Yet Recruiting

75

General University Hospital of Patras

Pátrai, Greece, 265 04

Not Yet Recruiting

76

Aartham Multi Super Speciality Hospital

Ahmedabad, India, 380015

Not Yet Recruiting

77

AIIMS Bhubaneshwar

Bhubaneswar, India, 751019

Not Yet Recruiting

78

Government Medical College

Kozhikode, India, 673008

Not Yet Recruiting

79

Noble Hospital Pvt Ltd

Pune, India, 411013

Not Yet Recruiting

80

Galaxy Lifecare Services Pvt. Ltd.

Varanasi, India, 201010

Not Yet Recruiting

81

Azienda Ospedaliero Universitaria delle Marche

Ancona, Italy, 60126

Not Yet Recruiting

82

Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

Bari, Italy, 70124

Not Yet Recruiting

83

Policlinico S. Orsola-Malpighi

Bologna, Italy, 40138

Not Yet Recruiting

84

A.O.U.Policlinico G.Martino

Messina, Italy, 98124

Not Yet Recruiting

85

Asst Santi Paolo E Carlo

Milan, Italy, 20142

Not Yet Recruiting

86

Fondazione Salvatore Maugeri

Pavia, Italy, 27100

Not Yet Recruiting

87

IRCCS Ospedale "Casa Sollievo della Sofferenza"

San Giovanni Rotondo (FG), Italy, 71013

Not Yet Recruiting

88

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy, 37126

Not Yet Recruiting

89

Kasugai Municipal Hospital

Aichi, Kasugai, Japan, 486-8510

Not Yet Recruiting

90

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Aichi, Nagoya, Japan, 466-8650

Not Yet Recruiting

91

Japanese Red Cross Fukuoka Hospital

Fukuoka, Fukuoka, Japan, 815-8555

Not Yet Recruiting

92

Kobe University Hospital

Hyogo, Kobe, Japan, 650-0017

Not Yet Recruiting

93

The Jikei University Hospital

Tokyo, Minato-ku, Japan, 105-8471

Not Yet Recruiting

94

Tokyo Women's Medical University Hospital

Tokyo, Shinjuku-ku, Japan, 162-8666

Not Yet Recruiting

95

Hospital Selayang

Batu Caves, Malaysia, 68100

Not Yet Recruiting

96

Hospital Sultan Idris Shah Serdang

Kajang, Malaysia, 43000

Not Yet Recruiting

97

Sunway Medical Centre

Selangor Darul Ehsan, Malaysia, 47500

Not Yet Recruiting

98

Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico, 14080

Not Yet Recruiting

99

Amsterdam UMC Locatie AMC

Amsterdam, Netherlands, 1105 AZ

Not Yet Recruiting

100

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Not Yet Recruiting

101

Pacific Clinical Research Network - Auckland

Auckland, New Zealand, 622

Not Yet Recruiting

102

Waikato Hospital

Hamilton, New Zealand, 3204

Not Yet Recruiting

103

Akershus Universitetssykehus HF

Lørenskog, Norway, 1478

Not Yet Recruiting

104

Oslo Universitetssykehus HF, Ullevål sykehus

Oslo, Norway, 0450

Not Yet Recruiting

105

Helse Stavanger, Stavanger Universitetssykehus

Stavanger, Norway, N-4011

Not Yet Recruiting

106

Universitetssykehuset Nord-Norge, Tromsø

Tromsø, Norway, 9019

Not Yet Recruiting

107

Central Clinical Hospital of the Medical University of Lodz

Lodz, Poland, 92-213

Not Yet Recruiting

108

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

Poznan, Poland, 60-355

Not Yet Recruiting

109

Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie

Szczecin, Poland, 70-111

Not Yet Recruiting

110

Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie

Warsaw, Poland, 02-091

Not Yet Recruiting

111

Central Clinical Hospital of the Ministry of National Defence - Military Institute of Medicine

Warsaw, Poland, 04-141

Not Yet Recruiting

112

Unidade Local de Saúde de Almada-Seixal E.P.E.

Almada, Portugal, 2805-267

Not Yet Recruiting

113

ULS Braga

Braga, Portugal, 4710-243

Not Yet Recruiting

114

ULS de Santa Maria, E.P.E

Lisbon, Portugal, 1649-035

Not Yet Recruiting

115

Unidade Local de Saúde Lisboa Occidental, E.P.E

Lisbon, Portugal, 2790-134

Not Yet Recruiting

116

ULS de Loures-Odivelas, E.P.E

Loures, Portugal, 2674-514

Not Yet Recruiting

117

Institutul Clinic Fundeni

Bucharest, Romania, 022328

Not Yet Recruiting

118

County Emergency Hospital "Pius Brinzeu" Timisoara

Timișoara, Romania, 300723

Not Yet Recruiting

119

Singapore General Hospital

Singapore, Singapore, 169608

Not Yet Recruiting

120

Tan Tock Seng Hospital

Singapore, Singapore, 308433

Not Yet Recruiting

121

F D Roosevelt University General Hospital Of Banska Bystrica

Banská Bystrica, Slovakia, 975 17

Not Yet Recruiting

122

University Hospital and Comenius University in Bratislava, Derer´s Hospital

Bratislava, Slovakia, 833 05

Not Yet Recruiting

123

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia, 041 90

Not Yet Recruiting

124

FMC Dialysis Services Kosice

Košice, Slovakia, 40190

Not Yet Recruiting

125

Univ. Hospital Martin

Martin, Slovakia, 036 01

Not Yet Recruiting

126

Kyung Hee University Hospital at Gangdong

Seoul, South Korea, 05278

Not Yet Recruiting

127

Ajou University Hospital

Suwon, South Korea, 16499

Not Yet Recruiting

128

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Not Yet Recruiting

129

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Not Yet Recruiting

130

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Not Yet Recruiting

131

Danderyds Sjukhus

Danderyd, Sweden, 182 88

Not Yet Recruiting

132

Universitetssjukhuset, Linköping

Linköping, Sweden, 581 85

Not Yet Recruiting

133

Uppsala University Hospital

Uppsala, Sweden, 751 85

Not Yet Recruiting

134

Klinik Hirslanden

Zurich, Switzerland, 8032

Not Yet Recruiting

135

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Taiwan, 235

Actively Recruiting

136

China Medical University Hospital

Taichung, Taiwan, 40447

Not Yet Recruiting

137

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Not Yet Recruiting

138

National Taiwan University Hospital

Taipei, Taiwan, 100225

Not Yet Recruiting

139

Adana City Hospital

Adana, Turkey (Türkiye), 01220

Not Yet Recruiting

140

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye), 06200

Not Yet Recruiting

141

Bursa Uludag University

Bursa, Turkey (Türkiye), 16110

Not Yet Recruiting

142

İstanbul Çapa University

Istanbul, Turkey (Türkiye), 34093

Not Yet Recruiting

143

Kocaeli University Faculty of Medicine Hospital

İzmit, Turkey (Türkiye), 41000

Not Yet Recruiting

144

Erciyes University

Melikgazi/Kayseri, Turkey (Türkiye), 38039

Not Yet Recruiting

145

Bradford Institute for Health Research

Bradford, United Kingdom, BD9 6RJ

Actively Recruiting

146

The Royal London Hospital

London, United Kingdom, E1 1BB

Actively Recruiting

147

King's College Hospital

London, United Kingdom, SE5 9RS

Actively Recruiting

148

Salford Royal

Salford, United Kingdom, M6 8HD

Not Yet Recruiting

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Research Team

B

Boehringer Ingelheim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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