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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Corbridge Group Philippines, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Alfa Wassermann S.p.A.
Information provided by:
Corbridge Group Philippines, Inc.
ClinicalTrials.gov Identifier:
NCT01000545
First received: October 22, 2009
Last updated: October 29, 2009
Last verified: October 2009

October 22, 2009
October 29, 2009
November 2009
January 2011   (final data collection date for primary outcome measure)
macroalbuminuria and serum creatinine [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01000545 on ClinicalTrials.gov Archive Site
adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: Sulodexide
    SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
    Other Names:
    • Sulodexide
    • 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 Comparator: placebo gelcaps + 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)
    Intervention: Drug: placebo capsules
  • Active Comparator: SLX 500LRU/day + best medical treatment
    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)
    Intervention: Drug: Sulodexide
  • Active Comparator: SLX 1000LRU/day + best medical treatment
    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)
    Intervention: Drug: Sulodexide
  • Active Comparator: SLX 2000LRU/day + best medical treatment
    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)
    Intervention: Drug: Sulodexide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1508
December 2012
January 2011   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Arlene C Crisostomo, M.D., MSc. 639189004532 arlene_crisostomo_md@yahoo.com
Contact: Kathrina B Imperial 6324487933 ext 116 kaye_imperial2004@yahoo.com
Philippines
 
NCT01000545
SLD-CKD-001
Yes
Mr. German A. Panghulan, Corbridge Group Philippines, Inc.
Corbridge Group Philippines, Inc.
Alfa Wassermann S.p.A.
Not Provided
Corbridge Group Philippines, Inc.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP