| Trial ID: | L1028 |
| Source ID: | NCT01197235
|
| Associated Drug: |
Darbepoetin-Α
|
| Title: |
Effect of Darbepoetin in Contrast-induced Nephropathy
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Acute Kidney Injury
|
| Interventions: |
DRUG: darbepoetin-α|DRUG: isotonic saline
|
| Outcome Measures: |
Primary: incidence of contrast-induced nephropathy (CIN), a greater than 25 percent increase in serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using the contrast agent, 48 hours | Secondary: maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention), the maximum difference in Cr levels before and after CAG or PCI, the incidence of AKI requiring renal replacement therapy, length of hospital stay, mortality, myocardial infarction, revascularization, and the occurrence of stroke, 1 month after the intervention
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Bundang Hospital | Collaborators: SMG-SNU Boramae Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2009-05
|
| Completion Date: |
2015-12
|
| Results First Posted: |
|
| Last Update Posted: |
2014-11-21
|
| Locations: |
Seoul National University Bundang Hospital,, Seongnam, 463-707, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01197235
|
