Trial | NCT01000545  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    sulodexide ...

  • Study Participants

    1508
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
Study Started
Nov 30
2009
Primary Completion
Jan 31
2011
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Oct 30
2009
Estimate

Drug Sulodexide

SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.

  • Other names: Vessel Due-F, SLX, Glycosaminoglycans

Drug placebo capsules

8 soft-gel capsules per day to be taken orally for 12 months

  • Other names: placebo, placebo gelcaps

placebo gelcaps + best medical treatment Placebo Comparator

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 Active Comparator

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 1000LRU/day + best medical treatment Active Comparator

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)

SLX 2000LRU/day + best medical treatment Active Comparator

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)

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
No Results Posted