AzTrials
AzTrials

Acute Kidney InjuryEarly Phase 1NCT04890704

Curcuminoids and Contrast-induced Acute Kidney Injury

A Early Phase 1 study testing Curcuminoid in people with Acute Kidney Injury and Contrast Media Toxicity, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this study was to evaluate the role of curcuminoids in the prevention of CI-AKI in CKD patients.The result of the study was prophylactic administration with curcuminoids in addition to standard treatment reduce the incidence of CI-AKI CKD patients undergoing elective CAG. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Curcuminoid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteThailand
Study dates
1 Oct 2018to 31 May 2019
Phase
Early Phase 1
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All the patients undergoing elective CAG at Vajira hospital from October 2018 to March 2019 were included in the study
  • older than 18 years old
  • stable eGFR 15-60 mL/min/1.73m2 in last 3 months.

Who cannot join

  • dialysis-dependent
  • post-kidney transplantation
  • acute heart failure or critically ill
  • history of contrast or turmeric allergy
  • increasing of alanine aminotransferase (ALT) or alkaline phosphatase (ALP) more than three times of normal upper limits or post-cholecystectomy
  • history of AKI (as evidence by sCr change ≥ 0.3 mg/dL) within 14 days before the study - using medication included NSAIDs, warfarin, immunosuppression, N-acetyl cysteine, ascorbic acid or contrast agents within 14 days before the study
  • pregnancy or lactation o
  • denied consent .

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Navamindradhiraj University

    Bangkok, 10300

Other trials in Thailand

About this study

Official title: Curcuminoids Can Prevent Contrast-induced Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Elective Coronary Procedures: A Randomized Controlled Trial

The objective of this study was to evaluate the role of curcuminoids in the prevention of CI-AKI in CKD patients.The result of the study was prophylactic administration with curcuminoids in addition to standard treatment reduce the incidence of CI-AKI CKD patients undergoing elective CAG.

Read the detailed description

This study was a single-center, prospective, double-blinded, randomized placebo-controlled trial in CKD patients undergoing elective coronary angiography (CAG) at Vajira hospital from October 2018 to March 2019. Patients were stratified according to baseline estimate glomerular filtration rate (eGFR) and diabetes status. They were randomized to Curcuminoids 1,500 milligrams per day starting 3 days before and 2 days after coronary procedure or placebo. The primary outcome was the development of CI-AKI, defined as serum creatinine rising ≥ 0.3 mg/dL within 48 hours after coronary angiography. The secondary outcomes were overall AKI incidences within 7 days after CAG, changes in eGFR, IL-6 hs-CRP, and other adverse events.

A total of 60 patients were enrolled( 30 in curcuminoids group, and 30 in the control group). Overall AKI developed in 5 patients in control group and none in curcuminoids group (16.67% versus 0%, p-value 0.052). The results showed that curcuminoids could preserve changes in eGFR compared to the placebo group (-1.5 vs 2.5 mL/min/1.73m2, p-value <0.001 within 48 hours and -4 versus 1 mL/min/1.73m2, p-value 0.002 within 7 days). The high-sensitive C-reactive protein (hs-CRP) and IL-6 levels were not different between patients receiving curcuminoids and placebo. In curcuminoids group, 3 patients developed mild nausea and diarrhea that improved with supportive care. No serious adverse events were found in both groups.

Being tested
Curcuminoid, Placebo
Keywords
contrast-induced acute kidney injury, Curcuminoids, coronary angiography
Medical subject headings
Acute Kidney Injury, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurcuminoidDrug

    Patients were stratified according to baseline eGFR and diabetes status with 1:1 assignment into curcuminoids and placebo group. Curcuminoids (250 mg capsules) were purchased from the Government Pharmaceutical Organization of Thailand (Anti-ox® registration number 1A 1/60(H)), which contained curcumin: demethoxycurcumin: bis-demothoxycurcumin at the ratio of 1:0.5:0.2.

  • PlaceboDrug

    Identical capsules were used for the placebo from the same manufacturer.

Study groups in NCT04890704
Study groupRoleWhat they receive
CurcumioidsExperimentalThe investogators prescribed curcuminoids 1,500 mg/day . The regimen was curcuminoids 500 mg three times a day from three days before the procedure until two days after. All patients also received standard prophylaxis protocol which included 0.9% sodium chloride 1 mL/kg/hour, given 12 hours before and 12 hours after CAG unless contraindicated.
Receives: Drug: Curcuminoid
PlaceboPlacebo comparatorThe placebo was identical capsule given three times daily and the remaining protocols were the same as the active group
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of AKI

    the incidence of CI-AKI development between the addition of curcuminoids to standard protocol and standard protocol alone in patients who underwent CAG

    Measured: 48 hours

Secondary outcomes (4)

  1. AKI of any cause within seven days after CAG

    The incidence overallof AKI form any causes

    Measured: 7 days

  2. Change in eGFR

    The final eGFR compared to baseline eGFR before CAG

    Measured: 0,7 days

  3. Change in IL-6 and hs-CRP

    The final levels of inflammatory markers at the completion of study compare to baseline

    Measured: 0.7 days

  4. Adverse events

    The adverse events of curcuminoids

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start1 Oct 2018
  3. Primary completion31 Mar 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, double-blinded, randomized placebo-controlled study
Masking
Single blind
Who is masked
Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04890704
Sponsor's protocol ID
157/61
Status last verified
May 2021
First submitted
13 May 2021
Last updated
18 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After pub

Publications

  • Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. doi: 10.1053/ajkd.2002.32766.

    PubMed 11979336

  • Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. N Engl J Med. 2019 May 30;380(22):2146-2155. doi: 10.1056/NEJMra1805256. No abstract available.

    PubMed 31141635

  • Morcos R, Kucharik M, Bansal P, Al Taii H, Manam R, Casale J, Khalili H, Maini B. Contrast-Induced Acute Kidney Injury: Review and Practical Update. Clin Med Insights Cardiol. 2019 Nov 1;13:1179546819878680. doi: 10.1177/1179546819878680. eCollection 2019.

    PubMed 31700251

  • Kusirisin P, Chattipakorn SC, Chattipakorn N. Contrast-induced nephropathy and oxidative stress: mechanistic insights for better interventional approaches. J Transl Med. 2020 Oct 20;18(1):400. doi: 10.1186/s12967-020-02574-8.

    PubMed 33081797

  • Tasanarong A, Vohakiat A, Hutayanon P, Piyayotai D. New strategy of alpha- and gamma-tocopherol to prevent contrast-induced acute kidney injury in chronic kidney disease patients undergoing elective coronary procedures. Nephrol Dial Transplant. 2013 Feb;28(2):337-44. doi: 10.1093/ndt/gfs525. Epub 2013 Jan 12.

    PubMed 23314316

  • Weisbord SD, Gallagher M, Jneid H, Garcia S, Cass A, Thwin SS, Conner TA, Chertow GM, Bhatt DL, Shunk K, Parikh CR, McFalls EO, Brophy M, Ferguson R, Wu H, Androsenko M, Myles J, Kaufman J, Palevsky PM; PRESERVE Trial Group. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine. N Engl J Med. 2018 Feb 15;378(7):603-614. doi: 10.1056/NEJMoa1710933. Epub 2017 Nov 12.

    PubMed 29130810

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Curcuminoid in people with Acute Kidney Injury and Contrast Media Toxicity, run by Bangkok Metropolitan Administration Medical College and Vajira 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 8 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: finished, as of the sponsor's last update on 18 May 2021. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of 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?

On the ClinicalTrials.gov record for NCT04890704, which also lists 6 linked publications.

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 18 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in