Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

PHASE2RecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

January 18, 2024

Primary Completion Date

December 4, 2025

Study Completion Date

February 20, 2026

Conditions
Acute Kidney Injury Due to Sepsis
Interventions
BIOLOGICAL

TIN816 70 mg lyophilisate powder

Immunotherapy Recombinant human CD39 enzyme

OTHER

Placebo

0.9% sterile saline solution

Trial Locations (118)

1200

RECRUITING

Novartis Investigative Site, Brussels

1340

RECRUITING

Novartis Investigative Site, Ottignies

3084

RECRUITING

Novartis Investigative Site, Heidelberg

3600

RECRUITING

Novartis Investigative Site, Genk

4029

RECRUITING

Novartis Investigative Site, Herston

4032

RECRUITING

Novartis Investigative Site, Debrecen

6020

RECRUITING

Novartis Investigative Site, Innsbruck

9000

RECRUITING

Novartis Investigative Site, Ghent

10330

RECRUITING

Novartis Investigative Site, Bangkok

10400

RECRUITING

Novartis Investigative Site, Bangkok

10461

RECRUITING

Montefiore Medical Center, The Bronx

10467

RECRUITING

Montefiore Medical Center, The Bronx

10700

RECRUITING

Novartis Investigative Site, Bangkok

11407

WITHDRAWN

Novartis Investigative Site, Jerez de la Frontera

13915

RECRUITING

Novartis Investigative Site, Marseille

14004

RECRUITING

Novartis Investigative Site, Córdoba

15213

RECRUITING

U Of Pittsburgh Med Ctr, Pittsburgh

15706

RECRUITING

Novartis Investigative Site, Santiago de Compostela

19140

RECRUITING

Temple University, Philadelphia

20089

RECRUITING

Novartis Investigative Site, Rozzano

20100

RECRUITING

Novartis Investigative Site, Milan

20162

RECRUITING

Novartis Investigative Site, Milan

22042

WITHDRAWN

Inova Fairfax Hospital, Falls Church

23298

RECRUITING

Virginia Commonwealth University, Richmond

24105

RECRUITING

Novartis Investigative Site, Kiel

28041

RECRUITING

Novartis Investigative Site, Madrid

30097

RECRUITING

Emory Johns Creek Hospital, Johns Creek

31054

RECRUITING

Novartis Investigative Site, Toulouse

33604

RECRUITING

Novartis Investigative Site, Pessac

34093

WITHDRAWN

Novartis Investigative Site, Istanbul

35128

RECRUITING

Novartis Investigative Site, Padua

40138

RECRUITING

Novartis Investigative Site, Bologna

43210

RECRUITING

Ohio State University Medical Center, Columbus

44093

RECRUITING

Novartis Investigative Site, Nantes

45147

RECRUITING

Novartis Investigative Site, Essen

46026

RECRUITING

Novartis Investigative Site, Valencia

48149

RECRUITING

Novartis Investigative Site, Münster

49933

RECRUITING

Novartis Investigative Site, Angers

50200

RECRUITING

Novartis Investigative Site, Chiang Mai

52242

RECRUITING

Univ Of Iowa Hospitals And Clinics, Iowa City

WITHDRAWN

Univ Of Iowa Hospitals And Clinics, Iowa City

55905

RECRUITING

Mayo Clinic Rochester, Rochester

60590

RECRUITING

Novartis Investigative Site, Frankfurt am Main

60611

RECRUITING

Northwestern Memorial Hospital, Evanston

67091

RECRUITING

Novartis Investigative Site, Strasbourg

70376

RECRUITING

Novartis Investigative Site, Stuttgart

75010

WITHDRAWN

Novartis Investigative Site, Paris

75246

RECRUITING

Baylor Scott and White, Dallas

80131

RECRUITING

Novartis Investigative Site, Napoli

81377

RECRUITING

Novartis Investigative Site, München

84107

RECRUITING

Utah Intermountain Medical Center, Murray

87000

RECRUITING

Novartis Investigative Site, Limoges

92380

RECRUITING

Novartis Investigative Site, Garches

94275

RECRUITING

Novartis Investigative Site, Le Kremlin-Bicêtre

95107

RECRUITING

Novartis Investigative Site, Argenteuil

97330

RECRUITING

Good Samaritan Hospital, Corvallis

99204

WITHDRAWN

Providence Med Resch Center and Chindren Hosp, Spokane

100730

RECRUITING

Novartis Investigative Site, Beijing

110001

RECRUITING

Novartis Investigative Site, Delhi

310014

RECRUITING

Novartis Investigative Site, Hangzhou

430022

RECRUITING

Novartis Investigative Site, Wuhan

450003

RECRUITING

Novartis Investigative Site, Zhengzhou

500034

RECRUITING

Novartis Investigative Site, Hyderabad

510260

RECRUITING

Novartis Investigative Site, Guangzhou

590010

RECRUITING

Novartis Investigative Site, Belagavi

94143-0116

RECRUITING

UC San Francisco Medical Center, San Francisco

94305 5152

RECRUITING

Stanford Healthcare, Stanford

02114

RECRUITING

Massachusetts General Hospital, Boston

01805

RECRUITING

Lahey Hospital and Medical Center, Burlington

01199

RECRUITING

Baystate Medical Center, Springfield

48202 2689

WITHDRAWN

Henry Ford Hospital, Detroit

27157-1071

RECRUITING

Wake Forest Univ School of Medicine, Winston-Salem

C1118AAT

RECRUITING

Novartis Investigative Site, CABA

C1181ACH

RECRUITING

Novartis Investigative Site, CABA

B1629AHJ

RECRUITING

Novartis Investigative Site, Pilar

S3000EPV

RECRUITING

Novartis Investigative Site, Santa Fe

70390-140

RECRUITING

Novartis Investigative Site, Brasília

80010 030

RECRUITING

Novartis Investigative Site, Curitiba

09090-790

RECRUITING

Novartis Investigative Site, Santo André

01327 001

RECRUITING

Novartis Investigative Site, São Paulo

40301-155

RECRUITING

Novartis Investigative Site, Salvador

V6Z 1Y6

RECRUITING

Novartis Investigative Site, Vancouver

K7L 2V7

RECRUITING

Novartis Investigative Site, Kingston

H2W 1T8

RECRUITING

Novartis Investigative Site, Montreal

H4J 1C5

RECRUITING

Novartis Investigative Site, Montreal

G1V 4G5

RECRUITING

Novartis Investigative Site, Sainte-Foy

050011

RECRUITING

Novartis Investigative Site, Shijiazhuang

07740

RECRUITING

Novartis Investigative Site, Jena

H-1097

RECRUITING

Novartis Investigative Site, Budapest

H-9024

RECRUITING

Novartis Investigative Site, Győr

H-8000

RECRUITING

Novartis Investigative Site, Székesfehérvár

380 060

RECRUITING

Novartis Investigative Site, Ahmedabad

411 011

RECRUITING

Novartis Investigative Site, Pune

06129

RECRUITING

Novartis Investigative Site, Perugia

00168

RECRUITING

Novartis Investigative Site, Roma

296-8602

RECRUITING

Novartis Investigative Site, Kamogawa

812-8582

RECRUITING

Novartis Investigative Site, Fukuoka

078 8510

RECRUITING

Novartis Investigative Site, Asahikawa

245-8575

RECRUITING

Novartis Investigative Site, Yokohama

860-0008

RECRUITING

Novartis Investigative Site, Kumamoto

598-8577

RECRUITING

Novartis Investigative Site, Izumisano

534-0021

RECRUITING

Novartis Investigative Site, Osaka

843-0393

RECRUITING

Novartis Investigative Site, Ureshino

693-0068

RECRUITING

Novartis Investigative Site, Izumo

193-0944

RECRUITING

Novartis Investigative Site, Hachiōji

173-8610

RECRUITING

Novartis Investigative Site, Itabashi-ku

862-8505

RECRUITING

Novartis Investigative Site, Kumamoto

0002

RECRUITING

Novartis Investigative Site, Pretoria

08907

RECRUITING

Novartis Investigative Site, L'Hospitalet de Llobregat

08208

RECRUITING

Novartis Investigative Site, Sabadell

08035

RECRUITING

Novartis Investigative Site, Barcelona

08221

WITHDRAWN

Novartis Investigative Site, Terrassa

08041

RECRUITING

Novartis Investigative Site, Barcelona

06230

WITHDRAWN

Novartis Investigative Site, Ankara

GU2 7XX

WITHDRAWN

Novartis Investigative Site, Guildford

B15 2TH

RECRUITING

Novartis Investigative Site, Birmingham

BS2 8HW

WITHDRAWN

Novartis Investigative Site, Bristol

SE1 7EH

RECRUITING

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY