A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

February 2, 2018

Primary Completion Date

October 2, 2019

Study Completion Date

October 10, 2019

Conditions
Diabetic Kidney Disease
Interventions
DRUG

Fulacimstat (BAY1142524)

25 mg BAY1142524 are given twice daily over a treatment period of 6 months

DRUG

Placebo

Matching placebo tablets are given twice daily over a treatment period of 6 months

Trial Locations (27)

2100

Rigshospitalet, Copenhagen

2730

Steno Diabetes Center Copenhagen, Gentofte Municipality

3400

Nordsjællands Hospital, Hillerød

6000

MCOMH Preventsia-2000, Stara Zagora

6400

Med Centre Diamedical 2013, Dimitrovgrad

9000

Med. Center Equita, Varna

15405

Complexo Hospitalario Universitario de Ferrol, Ferrol

16100

The Nazareth Trust Hospital EMMS, Nazareth

29185

Centralsjukhuset Kristianstad, Kristianstad

33520

TAYS TKI Keskus Tutkimusvastaanotto, Tampere

35128

A.O.U. di Padova, Padua

40138

Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim, Bologna

48960

Hospital de Galdakao, Galdakao

70100

Pihlajalinna ITE Kuopio, Kuopio

71013

IRCCS Casa Sollievo della Sofferenza, Foggia

80131

A.O.U. Policlinico Federico II Napoli, Napoli

5822012

Edith Wolfson Medical Center, Holon

6937947

DMC - Diabetes Medical Center, Tel Aviv

7030000

Shamir Medical Center (Assaf Harofeh), Ẕerifin

7830604

Barzilai Medical Center, Ashkelon

9112001

Hadassah Hebrew University Hospital Ein Kerem, Jerusalem

FI-90100

Terveystalo Oulu, Oulu

FIN-20520

Turun yliopistollinen keskussairaala, kantasairaala, Turku

08025

Hospital Fundació Puigvert, Barcelona

701 85

Universitetssjukhuset Örebro, Örebro

114 46

Akardo MedSite AB, Stockholm

162 68

S3 Clinical Research Centers, Vällingby

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT03412006 - A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease | Biotech Hunter | Biotech Hunter