Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients
Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 3, 2010
January 1, 2010
9 months
February 2, 2010
February 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group.
1 year
Secondary Outcomes (1)
The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups.
1 year
Study Arms (2)
alpha tocopherol
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
The patients were assigned to receive oral alpha tocopherol (525 IU) every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.
The patients were assigned to receive oral placebo every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.
Eligibility Criteria
You may qualify if:
- serum creatinine levels \> 1.2 mg/dL and baseline creatinine clearance levels \< 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)
You may not qualify if:
- patients with acute kidney injury
- end stage renal disease (requiring dialysis)
- unstable renal function (as evidenced by a change in serum creatinine of \> 0.5 mg/dL, or \> 25%, within 14 days prior to the study)
- allergy to any of the contrast agents
- mechanical ventilation
- suffered from congestive heart failure, cardiogenic shock or emergent angiography.
- receiving NAC, mannitol, diuretics, theophylline, dopamine, vitamin E or contrast agents within 14 days before the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adis Tasanarong
Khlong Luang, Pathumtani, 12121, Thailand
Related Publications (1)
Tasanarong A, Piyayotai D, Thitiarchakul S. Protection of radiocontrast induced nephropathy by vitamin E (alpha tocopherol): a randomized controlled pilot study. J Med Assoc Thai. 2009 Oct;92(10):1273-81.
PMID: 19845233RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adis Tasanarong, MD
Faculty of Medicine, Thammasat University (Rangsit Campus)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 3, 2010
Study Start
January 1, 2010
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
February 3, 2010
Record last verified: 2010-01