CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,056 enrolled
Drug / intervention
Sulodexide +1 moredrug
Likely dose
Sulodexide 100 mg orally (gelcaps)AI-extracted
Key inclusion· 5
  • ✓Type 2 diabetes mellitus diagnosis
  • ✓Serum creatinine ≤1.5 mg/dL
  • ✓Microalbuminuria: men 35-200 mg/g creatinine, women 45-200 mg/g creatinine
  • ✓Blood pressure controlled to <150/90 mmHg
Key exclusion· 11
  • ✕Type 1 diabetes or diabetes onset before age 18
  • ✕HbA1c >10%
  • ✕BMI ≥45 kg/m² (morbid obesity)
  • ✕Non-diabetic renal disease or renal allograft

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00130208
NCT00130208Phase 3Completed
CompareCT.gov

The Collaborative Study Group Trial: The Effect of Sulodexide in Patients With Type 2 Diabetes and Microalbuminuria

Keryx Biopharmaceuticals·interventional·Posted Aug 15, 2005·Updated Mar 23, 2018

In Brief

A Phase 3 clinical trial evaluating Sulodexide and Placebo for Diabetic Nephropathy. Completed, enrolled 1,056 participants across 3 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Nephropathy
CountriesAustralia, Netherlands, United States
CollaboratorsCollaborative Study Group (CSG)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2005
Enrollment StartAug 1, 2005
Primary CompletionJan 1, 2008
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.9 years ago

Interventions

Sulodexidedrug

100 mg sulodexide gelcaps

Placebodrug

0 mg gelcap