Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01874431
First received: June 7, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it is safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses will be compared to placebo.


Condition Intervention Phase
Diabetic Nephropathies
Drug: BAY94-8862
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of urinary albumin-to-creatinine ratio [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum potassium [ Time Frame: 7 days, 30 days, 60 days, 90 days ] [ Designated as safety issue: Yes ]
  • Change in renal function [ Time Frame: 30 days, 60 days, 90 days ] [ Designated as safety issue: Yes ]
  • Change in health-related quality of life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Health-related quality of life is assessed by the scores got from the Kidney Disease Quality of Life (KDQOL-36) and EuroQol Group 5 dimension, 3 level (EQ-5D-3L) questionnaires.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 745
Study Start Date: June 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAY94-8862 (1.25 mg)
1.25 mg dose oral once daily for 90 days
Drug: BAY94-8862
Experimental: BAY94-8862 (2.5 mg)
2.5 mg dose oral once daily for 90 days
Drug: BAY94-8862
Experimental: BAY94-8862 (5 mg)
5 mg dose oral once daily for 90 days
Drug: BAY94-8862
Experimental: BAY94-8862 (7.5 mg)
7.5 mg dose oral once daily for 90 days
Drug: BAY94-8862
Experimental: BAY94-8862 (10 mg)
10 mg dose oral once daily for 90 days
Drug: BAY94-8862
Experimental: BAY94-8862 (15 mg)
15 mg dose oral once daily for 90 days
Drug: BAY94-8862
Experimental: BAY94-8862 (20 mg)
20 mg dose oral once daily for 90 days
Drug: BAY94-8862
Placebo Comparator: Placebo
Placebo oral dose once daily for 90 days
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
  • Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.
  • Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

    • are on oral antidiabetics and / or insulin,
    • have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
    • have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
    • have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit
  • Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:

    • Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
    • Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
  • Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
  • Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

  • Non-diabetic renal disease
  • Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
  • UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
  • Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
  • Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
  • Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
  • Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874431

  Show 168 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01874431     History of Changes
Other Study ID Numbers: 16243, 2012-004179-38
Study First Received: June 7, 2013
Last Updated: March 5, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED - National Authority of Medicines and Health Products
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency

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

ClinicalTrials.gov processed this record on April 17, 2014