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Effect of Sulodexide in Early Diabetic Nephropathy

NCT00130208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1056

Last updated 2018-03-23

Study results available
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Summary

The purpose of the study is to determine whether treatment with sulodexide is effective in reducing the level of urine albumin excretion in patients with early diabetic kidney disease expressed as microalbuminuria.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

Sulodexide

100 mg sulodexide gelcaps

DRUG

Placebo

0 mg gelcap

Sponsors & Collaborators

  • Collaborative Study Group (CSG)

    collaborator NETWORK

  • Keryx Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Edmund J Lewis, M.D. · The Collaborative Study Group, Rush University Medical Center, Chicago, IL USA

  • Robert C Atkins, M.D. · The Collaborative Study Group, Monash Medical Center, Clayton, Victoria, AUSTRALIA

  • Dick deZeeuw, M.D. · The Collaborative Study Group, University of Groningen, NETHERLANDS

  • Itamar Raz, M.D. · The Collaborative Study Group, Hadassah University, Jerusalem, ISRAEL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-01-31
Completion
2008-02-29

Countries

  • United States
  • Australia
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00130208 on ClinicalTrials.gov