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Completed

NCT Number: NCT04890704

Curcuminoids and Contrast-induced Acute Kidney Injury

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.

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Key information

Conditions

Acute Kidney Injury Chronic Disease Chronic Kidney Diseases Contrast Media Toxicity Curcuminoid Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Navamindradhiraj University

Bangkok, 10300, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 .

Treatment and study plan

Curcuminoid

Drug

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.

Placebo

Drug

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

Primary outcomes

  1. The incidence of AKI

    Time frame: 48 hours

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

Secondary outcomes

  1. AKI of any cause within seven days after CAG

    Time frame: 7 days

    The incidence overallof AKI form any causes

  2. Change in eGFR

    Time frame: 0,7 days

    The final eGFR compared to baseline eGFR before CAG

  3. Change in IL-6 and hs-CRP

    Time frame: 0.7 days

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

  4. Adverse events

    Time frame: 7 days

    The adverse events of curcuminoids

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 18, 2021
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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