Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients

Phase 3

• Conditions: Contrast Induced Nephropathy
• Interventions: Drug: alpha tocopherol; Drug: placebo

• Registration Number: NCT01061320
• Lead Sponsor: Thammasat University

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.

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.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Last Update Submitted: 2010-02-02
• Study First Posted: 2010-02-03
• Last Update Posted: 2010-02-03
• Primary Completion: 2010-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alpha tocopherol	alpha tocopherol	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group.	1 year

Secondary Outcome Measures

Name	Time	Method
The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups.	1 year

Trial Locations

Locations (1)

Adis Tasanarong; 🇹🇭 Khlong Luang, Pathumtani, Thailand