Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients
This study is enrolling participants by invitation only.
Sponsor:
Thammasat University
Information provided by:
Thammasat University
ClinicalTrials.gov Identifier:
NCT01061320
First received: February 2, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Contrast Induced Nephropathy |
Drug: alpha tocopherol Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
alpha-Tocopherol
Tocopherol
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
U.S. FDA Resources
Further study details as provided by Thammasat University:
Primary Outcome Measures:
- The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: alpha tocopherol |
Drug: alpha tocopherol
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.
Other Name: Bio-E-vitamin
|
| Placebo Comparator: placebo |
Drug: placebo
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.
Other Name: jelly
|
Detailed Description:
Contrast-induced nephropathy (CIN) increases the likelihood of patient morbidity and mortality following coronary procedures. Contrast agents cause an acute deterioration in renal function via the generation of reactive oxygen species. Vitamin E (alpha tocopherol)was demonstrated to be anti-oxidant and anti-inflammation. The present study was designed to evaluate the administration of antioxidant vitamin E (alpha tocopherol) as a means of preventing CIN in these patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061320
Locations
| Thailand | |
| Adis Tasanarong | |
| Khlong Luang, Pathumtani, Thailand, 12121 | |
Sponsors and Collaborators
Thammasat University
Investigators
| Principal Investigator: | Adis Tasanarong, MD | Faculty of Medicine, Thammasat University (Rangsit Campus) |
More Information
Additional Information:
Publications:
| Responsible Party: | Adis Tasanarong, Faculty of Medicine, Thammasat University (Rangsit Campus) |
| ClinicalTrials.gov Identifier: | NCT01061320 History of Changes |
| Other Study ID Numbers: | MTU-I-1-53/52 |
| Study First Received: | February 2, 2010 |
| Last Updated: | February 2, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Thammasat University:
|
Alpha-Tocopherol (Vitamin E) Contrast induced nephropathy Chronic kidney disease Coronary procedures |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Alpha-Tocopherol Vitamin E Tocopherols Tocotrienols |
Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 21, 2013