NCT02455960

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

May 25, 2015

Last Update Submit

May 27, 2015

Conditions

Contrast Induced AKI

Outcome Measures

Primary Outcomes (1)

  • Incidence of Contrast-induced acute kidney injury (CI-AKI)

    48 hours

Secondary Outcomes (1)

  • Number of Adverse effects

    48 hours

Study Arms (2)

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

L-arginineDIETARY_SUPPLEMENT

Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention

Arginine
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Nephrology, Phramongkutklao Hospital

Rachatevee, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2015

First Posted

May 28, 2015

Study Start

September 1, 2014

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

TH(1)