Contrast Induced AKIPhase 4NCT02455960
Protective Effects of Oral L-Arginine CI-AKI
A Phase 4 study testing L-arginine in people with Contrast Induced AKI, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contrast Induced AKI
- What is being tested?
- L-arginine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2014to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Stable CKD stage 3-4 patients
- Patients undergoing elective contrast media injection
Who cannot join
- History of arginine allergy
- Acute kidney injury diagnosed within 4 weeks
- Active infection/sepsis
- Severe liver disease
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Nephrology, Phramongkutklao Hospital
Rachatevee, Bangkok, 10400
Nuttawut Siritaweesuk, MD., 66819019191, znak.iiz@gmaill.com
Nuttawut Siritaweesuk, MD.
About this study
Official title: Protective Effects of Oral L-Arginine Supplement in Patients With CKD After Intravenous Contrast Media Injection
This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients.
Read the 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.
- Conditions
- Contrast Induced AKI
- Being tested
- L-arginine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDietary supplement
Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Arginine | Experimental | Participants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast-induced acute kidney injury (CI-AKI)
Measured: 48 hours
Secondary outcomes (1)
Number of Adverse effects
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Induced AKIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455960
- Sponsor's protocol ID
- Arginine 01
- Status last verified
- May 2015
- First submitted
- 25 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Oral L-Arginine Supplement in Patients With CKD After Intravenous Contrast Media Injection
- ClinicalTrials.gov ID
- NCT02455960
- Acronym / sponsor ID
- Arginine 01
- Conditions
- Contrast Induced AKI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arginine | Experimental | Dietary Supplement: L-arginineParticipants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants need to take placebo (corn powder) 3 g/day orally for 3 days before CT with contrast media injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Stable CKD stage 3-4 patients
- Patients undergoing elective contrast media injection
Key exclusion criteria (4 listed)
- History of arginine allergy
- Acute kidney injury diagnosed within 4 weeks
- Active infection/sepsis
- Severe liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginineComparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention | Dietary supplement | Arginine |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Incidence of Contrast-induced acute kidney injury (CI-AKI)
Time frame: 48 hours
1 secondary outcome
Number of Adverse effects
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Related trials for Contrast Induced AKI
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruiting
The Effect of Hydration on the Prevention of CI-AKI in STEMI Patients Undergoing Primary PCI (Hydro-AKI Trial)
Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction, Contrast Induced AKI
RecruitingObservational study
Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI
Coronary Artery Disease, Acute Kidney Injury
RecruitingObservational study
Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury
Acute Kidney Injury
RecruitingPhase 4
Single-Center Prospective Study to Investigate the Difference in the Incidence of Contrast-Induced Nephropathy in High-Risk Patients With the Use of the Dye-Vert Plus System
AKI (Acute Kidney Injury) Due to Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-arginine in people with Contrast Induced AKI, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Contrast-induced acute kidney injury (CI-AKI) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.