Diabetic kidney disease MedDRA version: 9.1 Level: LLT Classification code 10012687 Term: Diabetic renal disease
Conditions
Sponsors
Speedel Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: Diagnosis and main criteria for inclusion at beginning of Screening Phase: • Male or female patient; 21 to 80 years of age. • Type 2 diabetes mellitus. • Glycosylated haemoglobin (HbA1c) = 6.5% and = 10%. • Diabetic kidney disease evidenced by: o Estimated glomerular filtration rate (eGFR) (by Modification of Diet in Renal Disease [MDRD] Study formula) = 45 mL/min/1.73 m2 (i.e., Kidney Disease Outcomes Quality Initiative-chronic kidney disease [KDOQI-CKD] Stage I, II and high-end III); and o Albuminuria = 34 mg/mmol and = 350 mg/mmol ACR or = 300 mg/24h and = 3.5 g/24h. • Systolic BP = 150 mm Hg and diastolic BP = 100 mm Hg, after sitting quietly for 10 minutes. • Body mass index = 35 kg/m2. Qualification criteria: Diagnosis and main criteria for inclusion at qualification visit (Study Visit 4): • Diabetic kidney disease evidenced by: o eGFR (by MDRD study formula) = 45 mL/min/1.73 m2 (i.e., KDOQI-CKD stage I, II and high-end III); and o Albuminuria = 34 mg/mmol and = 350 mg/mmol ACR or = 300 mg/24h and = 3.5 g/24h. • Systolic BP = 150 mm Hg and diastolic BP = 100 mm Hg, after sitting quietly for 10 minutes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria: • Type 1 diabetes mellitus. • Albuminuria of non-diabetic origin. • Renal transplant or nephrectomy. • Congestive heart failure (CHF) New York Heart Association Grade II to IV. • Any evidence of CHF on physical examination. • History of pulmonary oedema, liver cirrhosis, pleural effusion or ascites. • Any massive peripheral oedema (above 5 mm indentation). • Concomitant treatment with insulin sensitisers (glitazones) or dihydropyridines (L-type Ca+ antagonist) at Visit 4 in patients who also have peripheral oedema. • Unwillingness of either patient or investigator to discontinue concomitant use of ACE inhibitors or ARBs other than irbesartan at Week -8. • History of arrhythmia, known pacemaker, on anti-arrhythmic drugs, complete bundle branch block, or an absolute QT or QTc interval > 500 msec as measured by 12 lead electrocardiogram (ECG). • Recent (within 60 days) percutaneous transluminal coronary angioplasty (PTCA), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or any other major surgical intervention. • Recent (within 60 days) acute myocardial infarction, unstable angina, stroke or transient ischaemic attack. • Any history of life-threatening arrhythmias, or any patient at high risk for QT/QTc prolongation such as those with a family history of Long QT Syndrome, severe hypokalaemia, etc. • Haemoglobin =10 g/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dose-dependent effects of avosentan administered orally once daily on albuminuria, as measured by the albumin creatinine ratio (ACR), in type 2 diabetic patients with diabetic kidney disease;Secondary Objective: To determine the safety and tolerability of avosentan administered orally once daily in type 2 diabetic patients with diabetic kidney disease.;Primary end point(s): Relative change in ACR from Week 0 (Study Visit 5, baseline and randomisation) to Week 12 (Study Visit 9, end-of-treatment) | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Latvia, Slovakia
Outcome results
None listed