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

Phase 3

• Conditions: Chronic Kidney Disease
• Interventions: Drug: placebo capsules; Drug: Sulodexide

• Registration Number: NCT01000545
• Lead Sponsor: Corbridge Group Philippines, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Last Update Submitted: 2009-10-29
• Last Update Posted: 2009-10-30
• Study Start: 2009-11
• Primary Completion: 2011-01
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1508

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo gelcaps + best medical treatment	placebo capsules	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)
SLX 500LRU/day + best medical treatment	Sulodexide	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)
SLX 2000LRU/day + best medical treatment	Sulodexide	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)
SLX 1000LRU/day + best medical treatment	Sulodexide	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)

Primary Outcome Measures

Name	Time	Method
macroalbuminuria and serum creatinine	52 weeks

Secondary Outcome Measures

Name	Time	Method
adverse events	52 weeks

Trial Locations

Locations (7)

Mary Mediatrix Medical Center; 🇵🇭 Lipa City, Batangas, Philippines

Rizal Private Clinics; 🇵🇭 Metro Manila, Rizal, Philippines

Holy Child Hospital; 🇵🇭 Dumaguete City, Philippines

Victoriano R. Potenciano Medical Center; 🇵🇭 Mandaluyong City, Philippines

Metropolitan Medical Center; 🇵🇭 Manila, Philippines

The Medical City; 🇵🇭 Pasig City, Philippines

Manila Adventist Medical Center; 🇵🇭 Pasay City, Philippines