| Trial ID: | L7260 |
| Source ID: | NCT00734253
|
| Associated Drug: |
Pyridoxamine Dihydrochloride
|
| Title: |
Safety and Efficacy Study of Pyridorin in Patients With Nephropathy Due to Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetic Nephropathy
|
| Interventions: |
DRUG: Pyridoxamine Dihydrochloride|DRUG: Pyridoxamine Dihydrochloride|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in serum creatinine from baseline to end of study., 1 year | Secondary: SCr slope, change in PCR, Cystatin C slope and change from baseline., 1 Year
|
| Sponsor/Collaborators: |
Sponsor: NephroGenex, Inc. | Collaborators: Collaborative Study Group (CSG)|Medpace, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
317
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2008-08
|
| Completion Date: |
2010-08
|
| Results First Posted: |
|
| Last Update Posted: |
2015-10-28
|
| Locations: |
The Collaborative Study Group, Chicago, Illinois, 60607, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00734253
|
