| Trial ID: | L4649 |
| Source ID: | NCT00130208
|
| Associated Drug: |
Sulodexide
|
| Title: |
Effect of Sulodexide in Early Diabetic Nephropathy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00130208/results
|
| Conditions: |
Diabetic Nephropathy
|
| Interventions: |
DRUG: Sulodexide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria, The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom "therapeutic success" was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline, 26 Weeks|Number of Subjects With Greater Than 50% Reduction in Microalbuminuria, During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved., 26 Weeks | Secondary: Change in Serum Albumin From Baseline to End of 26 Weeks, 26 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Keryx Biopharmaceuticals | Collaborators: Collaborative Study Group (CSG)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1056
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-08
|
| Completion Date: |
2008-02
|
| Results First Posted: |
2018-03-23
|
| Last Update Posted: |
2018-03-23
|
| Locations: |
The Collaborative Study Group, Clinical Coordinating Center for U.S. and Canadian Clinics, Rush University Medical Center, Chicago, Illinois, 60612, United States|The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center, Melbourne, Victoria, 3168, Australia|The Collaborative Study Group, Clinical Coordinating Center for European Clinics, University of Groningen, Groningen, 9713 AV, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT00130208
|
