Type 2 Diabetic Microalbuminuria MedDRA version: 8.0 Level: LLT Classification code 10027525
Conditions
Interventions
Product Name: Sulodexide
Product Code: KRX-101
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Sulodexide
CAS Number: 57821-29-1
Current Sponsor code: KRX-101
Other descriptive name: Sulodexid
Sponsors
Keryx Biopharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The principle inclusion criteria for the study includes men and women with type 2 diabetes and persistent microalbuminuria (in men urine albumin creatinine ratio [ACR] 35 – 200 mg albumin/G creatinine [4.0 - 22.6 mg/mmol], in women urine ACR 45 – 200 mg albumin/G creatinine [5.1 – 22.6 mg/mmol] based on the geometric mean of 3 first voided AM urine samples at the qualifying visit [Visit 6]). Patient’s serum creatinine must be ?1.5 mg/dL at screening. 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: 1. Age of onset of type 2 diabetes 10.0%; 3. Morbid obesity defined as a body mass index (BMI) ?45 kg/m2; 4. Type 1 (insulin-dependent; juvenile onset) diabetes; 5. Renal disease as follows: Patients with known non-diabetic renal disease (nephrosclerosis superimposed on diabetic nephropathy acceptable); Renal allograft; 6. Absolute requirement for combination therapy of ACEI and ARB; 7. Known allergies or intolerance to any heparin-like compound; 8. Untreated urinary tract infection that would impact urinary protein values; or 9. Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to determine the safety and efficacy of sulodexide in the treatment of patients with type 2 diabetes and persistent microalbuminuria, despite being treated with a maximum approved dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI). The primary efficacy measure will be the percentage of patients achieving “therapeutic success,” which is defined as a composite binary endpoint of conversion from microalbuminuria to normoalbuminuria (ACR 50% reduction in ACR level relative to baseline at Week 26. ;Secondary Objective: The secondary efficacy measures will include: 1) percentage of patients achieving normoalbuminuria at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively); 2) percentage of patients achieving >50% reduction in ACR from baseline at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively); 3) observed ACR, and change from baseline in ACR at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively); 4) percentage of patients reaching an ACR ?200 mg/G (22.6 mg/mmol) at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively); and 5) percentage change from baseline on various additional endpoints, including serum creatinine, Modification of Diet in Renal Disease (MDRD) estimated glomerular filtration rate (GFR), and serum albumin. ;Primary end point(s): Patients assigned to sulodexide 200 mg will achieve a significantly higher fraction of patients with “therapeutic success” at Week 26, as defined by the composite binary endpoint of conversion from microalbuminuria to normoalbuminuria (ACR 50% reduction in ACR level relative to baseline at Week 26. The primary efficacy analysis will be implemented by Fisher’s exact test. | — |
Countries
Denmark, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed