Korean Cohort Study of AKI & HRS in Cirrhosis

Acute Kidney Injury Clinical Trial

Official title:

Kidney Biomarkers for the Prediction of Response to Terlipressin and Survival in Cirrhotic Patients With Acute Kidney Injury: Multicenter, Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530761
• Other study ID #: P-KAKI
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2018
• Source: Soonchunhyang University Hospital
• Contact: Jeong-Ju Yoo, Doctor
• Phone: 82-10-9676-3128
• Email: puby17[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Fibrosis
• Hepatorenal Syndrome
• Liver Cirrhosis

Locations

Country	Name	City	State
Korea, Republic of	SoonChunHyang University Bucheon Hospital	Bucheon	Gyeonggi Do

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, Moreau R, Jalan R, Sarin SK, Piano S, Moore K, Lee SS, Durand F, Salerno F, Caraceni P, Kim WR, Arroyo V, Garcia-Tsao G. Diagnosis and management of acute kidney injury in patients with cirrhosis: — View Citation

Angeli P, Tonon M, Pilutti C, Morando F, Piano S. Sepsis-induced acute kidney injury in patients with cirrhosis. Hepatol Int. 2016 Jan;10(1):115-23. doi: 10.1007/s12072-015-9641-1. Epub 2015 Jul 4. Review. — View Citation

Ariza X, Solà E, Elia C, Barreto R, Moreira R, Morales-Ruiz M, Graupera I, Rodríguez E, Huelin P, Solé C, Fernández J, Jiménez W, Arroyo V, Ginès P. Analysis of a urinary biomarker panel for clinical outcomes assessment in cirrhosis. PLoS One. 2015 Jun 4; — View Citation

Barreto R, Elia C, Solà E, Moreira R, Ariza X, Rodríguez E, Graupera I, Alfaro I, Morales-Ruiz M, Poch E, Guevara M, Fernández J, Jiménez W, Arroyo V, Ginès P. Urinary neutrophil gelatinase-associated lipocalin predicts kidney outcome and death in patient — View Citation

Belcher JM, Garcia-Tsao G, Sanyal AJ, Thiessen-Philbrook H, Peixoto AJ, Perazella MA, Ansari N, Lim J, Coca SG, Parikh CR; TRIBE-AKI Consortium. Urinary biomarkers and progression of AKI in patients with cirrhosis. Clin J Am Soc Nephrol. 2014 Nov 7;9(11): — View Citation

Belcher JM, Sanyal AJ, Peixoto AJ, Perazella MA, Lim J, Thiessen-Philbrook H, Ansari N, Coca SG, Garcia-Tsao G, Parikh CR; TRIBE-AKI Consortium. Kidney biomarkers and differential diagnosis of patients with cirrhosis and acute kidney injury. Hepatology. 2 — View Citation

Fagundes C, Pépin MN, Guevara M, Barreto R, Casals G, Solà E, Pereira G, Rodríguez E, Garcia E, Prado V, Poch E, Jiménez W, Fernández J, Arroyo V, Ginès P. Urinary neutrophil gelatinase-associated lipocalin as biomarker in the differential diagnosis of im — View Citation

Helmersson-Karlqvist J, Ärnlöv J, Carlsson AC, Lind L, Larsson A. Urinary KIM-1, but not urinary cystatin C, should be corrected for urinary creatinine. Clin Biochem. 2016 Oct;49(15):1164-1166. doi: 10.1016/j.clinbiochem.2016.07.015. Epub 2016 Jul 28. — View Citation

Jaques DA, Spahr L, Berra G, Poffet V, Lescuyer P, Gerstel E, Garin N, Martin PY, Ponte B. Biomarkers for acute kidney injury in decompensated cirrhosis: A Prospective Study. Nephrology (Carlton). 2018 Jan 25. doi: 10.1111/nep.13226. [Epub ahead of print] — View Citation

Wong F, Murray P. Kidney damage biomarkers: Novel tools for the diagnostic assessment of acute kidney injury in cirrhosis. Hepatology. 2014 Aug;60(2):455-7. doi: 10.1002/hep.27063. Epub 2014 Jun 18. — View Citation

Wong F. The evolving concept of acute kidney injury in patients with cirrhosis. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):711-9. doi: 10.1038/nrgastro.2015.174. Epub 2015 Oct 20. Review. — View Citation

Yap DY, Seto WK, Fung J, Chok SH, Chan SC, Chan GC, Yuen MF, Chan TM. Serum and urinary biomarkers that predict hepatorenal syndrome in patients with advanced cirrhosis. Dig Liver Dis. 2017 Feb;49(2):202-206. doi: 10.1016/j.dld.2016.11.001. Epub 2016 Nov — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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	up to 3 years
Secondary	Transplantation free survival	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	up to 3 years
Secondary	Regression of acute kidney injury	Regression is defined as movement of AKI to a lower stage and decrease of serum creatinine	up to 1 month
Secondary	Recurrence of acute kidney injury	From sample collection day to elevation day of creatinine	up to 1 year
Secondary	Progression to chronic kidney disease	From sample collection day to progression to CKD	1 year
Secondary	Response rate to terlipressin	If reduction of creatinine 0.3mg/dL from the baseline	1 week