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

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Sulodexide
placebo capsules
Sponsored by
Corbridge Group Philippines, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Diabetes Mellitus, Chronic Kidney Disease, Glycosaminoglycans, Sulodexide, Macroalbuminuria, Safety and Efficacy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mary Mediatrix Medical Center
  • Rizal Private Clinics
  • Holy Child Hospital
  • Victoriano R. Potenciano Medical Center
  • Metropolitan Medical Center
  • Manila Adventist Medical Center
  • The Medical City

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

placebo gelcaps + best medical treatment

SLX 500LRU/day + best medical treatment

SLX 1000LRU/day + best medical treatment

SLX 2000LRU/day + best medical treatment

Arm 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)

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)

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)

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)

Outcomes

Primary Outcome Measures

macroalbuminuria and serum creatinine

Secondary Outcome Measures

adverse events

Full Information

First Posted
October 22, 2009
Last Updated
October 29, 2009
Sponsor
Corbridge Group Philippines, Inc.
Collaborators
Alfasigma S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01000545
Brief Title
The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease
Acronym
DEFINE
Official Title
The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Corbridge Group Philippines, Inc.
Collaborators
Alfasigma S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Diabetes Mellitus, Chronic Kidney Disease, Glycosaminoglycans, Sulodexide, Macroalbuminuria, Safety and Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1508 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo gelcaps + best medical treatment
Arm Type
Placebo Comparator
Arm 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)
Arm Title
SLX 500LRU/day + best medical treatment
Arm Type
Active Comparator
Arm 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)
Arm Title
SLX 1000LRU/day + best medical treatment
Arm Type
Active Comparator
Arm 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)
Arm Title
SLX 2000LRU/day + best medical treatment
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Sulodexide
Other Intervention Name(s)
Vessel Due-F, SLX, Glycosaminoglycans
Intervention Description
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Intervention Type
Drug
Intervention Name(s)
placebo capsules
Other Intervention Name(s)
placebo, placebo gelcaps
Intervention Description
8 soft-gel capsules per day to be taken orally for 12 months
Primary Outcome Measure Information:
Title
macroalbuminuria and serum creatinine
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arlene C Crisostomo, M.D., MSc.
Phone
639189004532
Email
arlene_crisostomo_md@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrina B Imperial
Phone
6324487933
Ext
116
Email
kaye_imperial2004@yahoo.com
Facility Information:
Facility Name
Mary Mediatrix Medical Center
City
Lipa City
State/Province
Batangas
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgardo Faustino, MD
Facility Name
Rizal Private Clinics
City
Metro Manila
State/Province
Rizal
Country
Philippines
Facility Name
Holy Child Hospital
City
Dumaguete City
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Coo
Facility Name
Victoriano R. Potenciano Medical Center
City
Mandaluyong City
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonietta D Dial, M.D.
Facility Name
Metropolitan Medical Center
City
Manila
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Y Gan, MD
Facility Name
Manila Adventist Medical Center
City
Pasay City
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gingerlita Samonte, MD
Facility Name
The Medical City
City
Pasig City
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth R Sebastian, MD, FPSN

12. IPD Sharing Statement

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

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