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Trial record 31 of 7879 for:    "Kidney Diseases"

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 (CADA DIA)

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ClinicalTrials.gov Identifier: NCT03412006
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Fulacimstat (BAY1142524) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fulacimstat (BAY1142524)
Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Drug: Fulacimstat (BAY1142524)
25 mg BAY1142524 are given twice daily over a treatment period of 6 months

Placebo Comparator: Placebo
Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Drug: Placebo
Matching placebo tablets are given twice daily over a treatment period of 6 months




Primary Outcome Measures :
  1. Change in urinary albumin to creatinine ratio (UACR) [ Time Frame: Baseline and at 6 months ]
    The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment


Secondary Outcome Measures :
  1. Number of patients with treatment-emergent adverse event [ Time Frame: From first intake of study drug up to 3 days after last administration of study drug ]
  2. Number of patients with serious adverse events [ Time Frame: From first intake of study drug up to 3 days after last administration of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412006


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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Bulgaria
Med Centre Diamedical 2013 Recruiting
Dimitrovgrad, Bulgaria, 6400
MCOMH Preventsia-2000 Recruiting
Stara Zagora, Bulgaria, 6000
Med. Center Equita Recruiting
Varna, Bulgaria, 9000
Denmark
Rigshospitalet Copenhagen Recruiting
Copenhagen, Denmark, 2100
Steno Diabetes Center Recruiting
Gentofte, Denmark, 2820
Nordsjællands Hospital Recruiting
Hillerød, Denmark, 3400
Finland
Pihlajalinna ITE Kuopio Recruiting
Kuopio, Finland, 70100
Terveystalo Oulu Recruiting
Oulu, Finland, FI-90100
TAYS TKI Keskus Tutkimusvastaanotto Recruiting
Tampere, Finland, 33520
Turun yliopistollinen keskussairaala, kantasairaala Recruiting
Turku, Finland, FIN-20520
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel, 7827804
Edith Wolfson Medical Center Recruiting
Holon, Israel, 58100
Hadassah Hebrew University Hospital Ein Kerem Recruiting
Jerusalem, Israel, 9112001
The Nazareth Trust Hospital EMMS Recruiting
Nazareth, Israel, 16100
DMC - Diabetes Medical Center Recruiting
Tel Aviv, Israel, 6937947
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 6093000
Italy
A.O.U. Policlinico Federico II Napoli Recruiting
Napoli, Campania, Italy, 80131
ASL Napoli 1 Centro Not yet recruiting
Napoli, Campania, Italy, 80138
Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim Not yet recruiting
Bologna, Emilia-Romagna, Italy, 40138
IRCCS Casa Sollievo della Sofferenza Recruiting
Foggia, Puglia, Italy, 71013
A.O. di Padova Recruiting
Padova, Veneto, Italy, 35128
Spain
Complexo Hospitalario Universitario de Ferrol Recruiting
Ferrol, A Coruña, Spain, 15405
Hospital de Galdakao Recruiting
Galdakao, Vizcaya, Spain, 48960
Hospital Fundació Puigvert Recruiting
Barcelona, Spain, 08025
Sweden
Centralsjukhuset Kristianstad Recruiting
Kristianstad, Sweden, 29185
Akardo MedSite AB Recruiting
Stockholm, Sweden, 114 46
S3 Clinical Research Centers Recruiting
Vällingby, Sweden, 162 68
Universitetssjukhuset Örebro Recruiting
Örebro, Sweden, 701 85
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03412006     History of Changes
Other Study ID Numbers: 18933
2017-000656-26 ( EudraCT Number )
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
type II diabetes
diabetic kidney disease

Additional relevant MeSH terms:
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Kidney Diseases
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Urologic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Complications