Protective Effects of Oral L-Arginine CI-AKI | NCT02455960

Studies
Protective Effects of Oral L-Arginine CI-AKI

NCT02455960

Sponsor

Phramongkutklao College of Medicine and Hospital

Status

Unknown status

Last Update Posted

May 28, 2015Estimated

Enrollment

112Estimated

Phase

Phase 4

Conditions

Contrast Induced AKI

Interventions

L-arginine
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

May 2016Estimated

First Submitted Date

May 25, 2015

First Submission Date that Met QC Criteria

May 27, 2015

First Posted Date

May 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients.

Detailed Description

Contrast-induced acute kidney injury (CI-AKI) is a common complication in hospitalized patients. Nitric oxide-signal transduction plays an important role in prevention of CI-AKI. L-Arginine is an amino acid involved in ammonia detoxification, and is well known as a precursor to nitric oxide, a key component of endothelial-derived relaxing factor.

This is a prospective randomized, double blind, placebo controlled trial among CKD stage 3-4 patients undergoing computer tomography. Eligible patients were randomly assigned to two groups: (1) arginine 3 g/day or 6 capsules per day, and (2) placebo 6 capsules per day for 3 days before contrast media injection. Serum cystatin C, serum creatinine and estimated GFR was measured at baseline and 48 hours after procedure.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arginine	Experimental	Participants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection	Dietary Supplement: L-arginine
Placebo	Placebo Comparator	Participants need to take placebo (corn powder) 3 g/day orally for 3 days before CT with contrast media injection	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-arginine	Dietary Supplement	Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention	Arginine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Contrast-induced acute kidney injury (CI-AKI)		48 hours

Secondary Outcomes

Measure	Description	Time Frame
Number of Adverse effects		48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Stable CKD stage 3-4 patients
Patients undergoing elective contrast media injection

Exclusion Criteria:

History of arginine allergy
Acute kidney injury diagnosed within 4 weeks
Active infection/sepsis
Severe liver disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Nephrology, Phramongkutklao Hospital	Recruiting	Rachatevee	Bangkok	10400	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D001120	Arginine

Ancestor Terms

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino

Browse Leaves

Not provided

Browse Branches

Not provided