The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).

Official Title
-----------------
The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Sulodexide
* Drug: placebo capsules


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo gelcaps + best medical treatment<br>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) | Drug: placebo capsules<br>* 8 soft-gel capsules per day to be taken orally for 12 months<br>* Other names: placebo gelcaps;|
| Active Comparator: SLX 500LRU/day + best medical treatment<br>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) | Drug: Sulodexide<br>* SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.<br>* Other names: Glycosaminoglycans;|
| Active Comparator: SLX 1000LRU/day + best medical treatment<br>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) | Drug: Sulodexide<br>* SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.<br>* Other names: Glycosaminoglycans;|
| Active Comparator: SLX 2000LRU/day + best medical treatment<br>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) | Drug: Sulodexide<br>* SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.<br>* Other names: Glycosaminoglycans;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macroalbuminuria and serum creatinine |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Chronic Kidney Disease, Glycosaminoglycans, Sulodexide, Macroalbuminuria, Safety and Efficacy