The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease (DEFINE)
Chronic Kidney Disease
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Diabetes Mellitus, Chronic Kidney Disease, Glycosaminoglycans, Sulodexide, Macroalbuminuria, Safety and Efficacy
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus
- positive 2 of 3 ACR > 300 mg/g or 24h urine protein or albumin collection > 300 mg/d in the absence of urinary tract infection
- serum creatinine 1.3 - 3 mg/dl in women and 1.5 - 3 mg/dl in men
Exclusion Criteria:
- age of onset of DM \< 18 years
- + renal disease like non-DM renal disease
- + CV diseases such as UA, MI, CABG
- + CVA or TIA within last 6 months
- untreated UTI
Sites / Locations
- Mary Mediatrix Medical Center
- Rizal Private Clinics
- Holy Child Hospital
- Victoriano R. Potenciano Medical Center
- Metropolitan Medical Center
- Manila Adventist Medical Center
- The Medical City
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
placebo gelcaps + best medical treatment
SLX 500LRU/day + best medical treatment
SLX 1000LRU/day + best medical treatment
SLX 2000LRU/day + best medical treatment
Patient will receive 4 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
Patient will receive 1 SLX gelcap and 3 placebo gelcaps twice a day.Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
Patient will receive 2 SLX gelcaps and 2 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
Patient will receive 4 SLX gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)