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

Contrast Induced Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01061320
• Other study ID #: MTU-I-1-53/52
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: February 2, 2010
• Last updated: February 2, 2010
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2010
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Adis Tasanarong	Khlong Luang	Pathumtani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group.		1 year	Yes
Secondary	The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups.		1 year	Yes

External Links

•   The Nephrology Society of Thailand
•   Toxicology data network