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
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
Drug: Sulodexide
Drug: placebo capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Corbridge Group Philippines, Inc.:

Primary Outcome Measures:
  • macroalbuminuria and serum creatinine [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1508
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: placebo capsules
8 soft-gel capsules per day to be taken orally for 12 months
Other Names:
  • placebo
  • placebo gelcaps
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)
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
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)
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
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)
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000545

Contacts
Contact: Arlene C Crisostomo, M.D., MSc. 639189004532 arlene_crisostomo_md@yahoo.com
Contact: Kathrina B Imperial 6324487933 ext 116 kaye_imperial2004@yahoo.com

Locations
Philippines
Mary Mediatrix Medical Center Not yet recruiting
Lipa City, Batangas, Philippines
Principal Investigator: Edgardo Faustino, MD         
Rizal Private Clinics
Metro Manila, Rizal, Philippines
Holy Child Hospital Not yet recruiting
Dumaguete City, Philippines
Principal Investigator: Kenneth Coo         
Victoriano R. Potenciano Medical Center Not yet recruiting
Mandaluyong City, Philippines
Principal Investigator: Antonietta D Dial, M.D.         
Metropolitan Medical Center Not yet recruiting
Manila, Philippines
Principal Investigator: Susan Y Gan, MD         
Manila Adventist Medical Center Not yet recruiting
Pasay City, Philippines
Principal Investigator: Gingerlita Samonte, MD         
The Medical City Not yet recruiting
Pasig City, Philippines
Principal Investigator: Elizabeth R Sebastian, MD, FPSN         
Sponsors and Collaborators
Corbridge Group Philippines, Inc.
Alfa Wassermann S.p.A.
  More Information

No publications provided

Responsible Party: Mr. German A. Panghulan, Corbridge Group Philippines, Inc.
ClinicalTrials.gov Identifier: NCT01000545     History of Changes
Other Study ID Numbers: SLD-CKD-001
Study First Received: October 22, 2009
Last Updated: October 29, 2009
Health Authority: Philippines: Bureau of Food and Drugs
Philippines: Philippine Council for Health Research and Development

Keywords provided by Corbridge Group Philippines, Inc.:
Diabetes Mellitus
Chronic Kidney Disease
Glycosaminoglycans
Sulodexide
Macroalbuminuria
Safety and Efficacy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014