Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Korean Cohort Study of AKI & HRS in Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530761
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Gyune Kim, Soonchunhyang University Hospital

Brief Summary:
The aim of this study is to investigate i) whether two biomarkers (urine NAG, urinary cystatin C) could be predictive factor in patient with liver cirrhosis, , and ii) whether these biomarkers can predict response of terlipressin.

Condition or disease
Liver Cirrhosis Acute Kidney Injury Hepatorenal Syndrome

Detailed Description:
Acute kidney injury (AKI) in patients with liver cirrhosis is sometimes accompanied by tubular injury which can lead to poor outcome. Current AKI criteria using serum creatinine (Cr) has some limitations to predict reversibility of renal function and discriminate renal parenchymal injury in cirrhotic patients. The aim of this study is to evaluate whether urine biomarkers [cystatin C, N-acetyl-β-D-Glucosaminidase (NAG)] can predict survival and response to terlipressin in cirrhotic patients with AKI.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 245 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Kidney Biomarkers for the Prediction of Response to Terlipressin and Survival in Cirrhotic Patients With Acute Kidney Injury: Multicenter, Prospective Cohort Study
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019


Group/Cohort
Acute kidney injury
Increase in serum creatinine more than 0.3 mg/dl within 48 hours or a percentage increase serum creatinine more than 50% from baseline.
Hepatorenal syndrome
  1. Diagnosis of cirrhosis and ascites,
  2. Diagnosis of AKI according to ICA-AKI criteria
  3. No response after 2 consecutive days of diuretic withdrawal and plasma volume expansion with albumin 1 g per kg of body weight
  4. Absence of shock
  5. No current or recent use of nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, iodinated contrast media, etc.)
  6. No macroscopic signs of structural kidney injury, defined as: absence of proteinuria (> 500 mg/day), absence of microhaematuria (> 50 RBCs per high power field), normal findings on renal ultrasonography.



Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]
    From date of sample collection until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years


Secondary Outcome Measures :
  1. Transplantation free survival [ Time Frame: up to 3 years ]
    From date of sample collection until the date of first liver transplantation or date of death from any cause, whichever came first, assessed up to 3 years

  2. Regression of acute kidney injury [ Time Frame: up to 1 month ]
    Regression is defined as movement of AKI to a lower stage and decrease of serum creatinine

  3. Recurrence of acute kidney injury [ Time Frame: up to 1 year ]
    From sample collection day to elevation day of creatinine

  4. Progression to chronic kidney disease [ Time Frame: 1 year ]
    From sample collection day to progression to CKD

  5. Response rate to terlipressin [ Time Frame: 1 week ]
    If reduction of creatinine 0.3mg/dL from the baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
Criteria

Inclusion Criteria:

  • Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
  • Patients who voluntarily agreed to the study

Exclusion Criteria:

  • Patients with active bleeding (eg, varix bleeding) within 7 days
  • Patients with hepatocellular carcinoma
  • Patients with hypersensitivity to terlipressin
  • Patients with anuria
  • Pregnant and lactating patients
  • Patients who did not agree with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530761


Contacts
Layout table for location contacts
Contact: Jeong-Ju Yoo, Doctor 82-10-9676-3128 puby17@naver.com

Locations
Layout table for location information
Korea, Republic of
SoonChunHyang University Bucheon Hospital Recruiting
Bucheon, Gyeonggi Do, Korea, Republic of, 14584
Contact: Sang Gyune Kim, Professor    82-32-621-5079    mcnulty@schmc.ac.kr   
Principal Investigator: Sang Gyune Kim         
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jeong-Ju Yoo, Doctor Soonchunhyang University Hospital

Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: Sang Gyune Kim, Associate proffesor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT03530761     History of Changes
Other Study ID Numbers: P-KAKI
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Hepatorenal Syndrome
Acute Kidney Injury
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases