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

Primary Purpose

Contrast Induced Nephropathy

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

alpha tocopherol

placebo

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Alpha-Tocopherol (Vitamin E), Contrast induced nephropathy, Chronic kidney disease, Coronary procedures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Adis Tasanarong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

alpha tocopherol

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01061320

First Posted

February 2, 2010

Last Updated

February 2, 2010

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT01061320

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Thammasat University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contrast Induced Nephropathy

Keywords

Alpha-Tocopherol (Vitamin E), Contrast induced nephropathy, Chronic kidney disease, Coronary procedures

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

alpha tocopherol

Arm Type

Active Comparator

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

alpha tocopherol

Other Intervention Name(s)

Bio-E-vitamin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

jelly

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adis Tasanarong, MD

Organizational Affiliation

Faculty of Medicine, Thammasat University (Rangsit Campus)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Adis Tasanarong

City

Khlong Luang

State/Province

Pathumtani

ZIP/Postal Code

12121

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

19845233

Citation

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.

Results Reference

result

Links:

URL

http://www.nephrothai.org/

Description

The Nephrology Society of Thailand

Learn more about this trial

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

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