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

Corbridge Group

Status and phase: Unknown; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: placebo capsules; Drug: Sulodexide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01000545

SLD-CKD-001

Details and patient eligibility

About

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

Enrollment: 1,508 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,508 participants in 4 patient groups, including a placebo group

placebo gelcaps + best medical treatment

Placebo Comparator group

Description:

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)

Treatment:

Drug: placebo capsules

SLX 500LRU/day + best medical treatment

Active Comparator group

Description:

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)

Treatment:

Drug: Sulodexide

SLX 1000LRU/day + best medical treatment

Active Comparator group

Description:

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)

Treatment:

Drug: Sulodexide

SLX 2000LRU/day + best medical treatment

Active Comparator group

Description:

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)

Treatment:

Drug: Sulodexide