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:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Tocopherols
Vitamin E
Alpha-Tocopherol
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 July 23, 2014