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

October 29, 2009 updated by: Corbridge Group Philippines, Inc.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1508

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Philippines
      • Dumaguete City, Philippines
        • Holy Child Hospital
        • Principal Investigator:
          • Kenneth Coo
      • Mandaluyong City, Philippines
        • Victoriano R. Potenciano Medical Center
        • Principal Investigator:
          • Antonietta D Dial, M.D.
      • Manila, Philippines
        • Metropolitan Medical Center
        • Principal Investigator:
          • Susan Y Gan, MD
      • Pasay City, Philippines
        • Manila Adventist Medical Center
        • Principal Investigator:
          • Gingerlita Samonte, MD
      • Pasig City, Philippines
        • The Medical City
        • Principal Investigator:
          • Elizabeth R Sebastian, MD, FPSN
    • Batangas
      • Lipa City, Batangas, Philippines
        • Mary Mediatrix Medical Center
        • Principal Investigator:
          • Edgardo Faustino, MD
    • Rizal
      • Metro Manila, Rizal, Philippines
        • Rizal Private Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • 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:
  • 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:
  • Vessel Due-F
  • SLX
  • Glycosaminoglycans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
macroalbuminuria and serum creatinine
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corbridge Group Philippines, Inc.

Collaborators

Alfasigma S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

October 30, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLD-CKD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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