Clinical trial 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
Official title: A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Kidney Disease
Keywords: type II diabetes
diabetic kidney disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-01-26
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.
* UACR \>50 mg/g and \<3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
* estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m\*2 and \<90 mL/min/1.73 m\*2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) at the screening visit and the baseline visit

Exclusion Criteria:

* Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
* Known bilateral clinical relevant renal artery stenosis (\>75%)
* New York Heart Association (NYHA) Class IV
* Acute kidney injury or dialysis within the last 3 months before the screening visit
* Renal replacement therapy during study conduct
* Renal allograft in place or a scheduled kidney transplant during study conduct
* Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit
* Clinically relevant hepatic dysfunction
* Uncontrolled hypertension as evidenced by systolic blood pressure \>160 mmHg, diastolic blood pressure \>100 mmHg (mean of triplicate values at the screening or baseline visit)

Primary outcomes:
measure: Change in urinary albumin to creatinine ratio (UACR)
timeFrame: Baseline and at 6 months
Secondary outcomes:
measure: Number of patients with treatment-emergent adverse event
timeFrame: From first intake of study drug up to 3 days after last administration of study drug
measure: Number of patients with serious adverse events
timeFrame: From first intake of study drug up to 3 days after last administration of study drug
Other outcomes:
Locations:
city: Dimitrovgrad
country: Bulgaria
facility: Med Centre Diamedical 2013
city: Stara Zagora
country: Bulgaria
facility: MCOMH Preventsia-2000
city: Varna
country: Bulgaria
facility: Med. Center Equita
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: København
country: Denmark
facility: Rigshospitalet
city: Kuopio
country: Finland
facility: Pihlajalinna ITE Kuopio
city: Oulu
country: Finland
facility: Terveystalo Oulu
city: Tampere
country: Finland
facility: TAYS TKI Keskus Tutkimusvastaanotto
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala, kantasairaala
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Hospital Ein Kerem
city: Nazareth
country: Israel
facility: The Nazareth Trust Hospital EMMS
city: Tel Aviv
country: Israel
facility: DMC - Diabetes Medical Center
city: Zerifin
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Napoli
country: Italy
facility: A.O.U. Policlinico Federico II Napoli
state: Campania
city: Bologna
country: Italy
facility: Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim
state: Emilia-Romagna
city: Foggia
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
state: Puglia
city: Padova
country: Italy
facility: A.O.U. di Padova
state: Veneto
city: Ferrol
country: Spain
facility: Complexo Hospitalario Universitario de Ferrol
state: A Coruña
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Fundació Puigvert
city: Kristianstad
country: Sweden
facility: Centralsjukhuset Kristianstad
city: Stockholm
country: Sweden
facility: Akardo MedSite AB
city: Vällingby
country: Sweden
facility: S3 Clinical Research Centers
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
Study officials:
References: