Liver CirrhosisNCT03530761
Korean Cohort Study of AKI & HRS in Cirrhosis
An observational study of Liver Cirrhosis and Acute Kidney Injury, run by Soonchunhyang University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome
- How many people
- 245 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 31 Dec 2019
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
Who may be able to join
- Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
- Patients who voluntarily agreed to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
SoonChunHyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
Sang Gyune Kim, Professor, 82-32-621-5079, mcnulty@schmc.ac.kr
Sang Gyune Kim
About this study
Official title: Kidney Biomarkers for the Prediction of Response to Terlipressin and Survival in Cirrhotic Patients With Acute Kidney Injury: Multicenter, Prospective Cohort Study
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.
Read the 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.
- Conditions
- Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome
- Medical subject headings
- Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 years
Secondary outcomes (5)
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
Measured: up to 3 years
Regression of acute kidney injury
Regression is defined as movement of AKI to a lower stage and decrease of serum creatinine
Measured: up to 1 month
Recurrence of acute kidney injury
From sample collection day to elevation day of creatinine
Measured: up to 1 year
Progression to chronic kidney disease
From sample collection day to progression to CKD
Measured: 1 year
Response rate to terlipressin
If reduction of creatinine 0.3mg/dL from the baseline
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Aug 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Gyune Kim, Soonchunhyang University Hospital
- Investigators
- Jeong-Ju Yoo, Doctor, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530761
- Sponsor's protocol ID
- P-KAKI
- Status last verified
- May 2018
- First submitted
- 25 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Helmersson-Karlqvist J, Arnlov 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.
PubMed 27475248Ariza X, Sola E, Elia C, Barreto R, Moreira R, Morales-Ruiz M, Graupera I, Rodriguez E, Huelin P, Sole C, Fernandez J, Jimenez W, Arroyo V, Gines P. Analysis of a urinary biomarker panel for clinical outcomes assessment in cirrhosis. PLoS One. 2015 Jun 4;10(6):e0128145. doi: 10.1371/journal.pone.0128145. eCollection 2015.
PubMed 26042740Angeli 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.
PubMed 26141259Wong 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. No abstract available.
PubMed 24700173Wong 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.
PubMed 26484442Jaques 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). 2019 Feb;24(2):170-180. doi: 10.1111/nep.13226.
PubMed 29369449Belcher 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. 2014 Aug;60(2):622-32. doi: 10.1002/hep.26980. Epub 2014 Jun 26.
PubMed 24375576Belcher 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):1857-67. doi: 10.2215/CJN.09430913. Epub 2014 Sep 2.
PubMed 25183658Fagundes C, Pepin MN, Guevara M, Barreto R, Casals G, Sola E, Pereira G, Rodriguez E, Garcia E, Prado V, Poch E, Jimenez W, Fernandez J, Arroyo V, Gines P. Urinary neutrophil gelatinase-associated lipocalin as biomarker in the differential diagnosis of impairment of kidney function in cirrhosis. J Hepatol. 2012 Aug;57(2):267-73. doi: 10.1016/j.jhep.2012.03.015. Epub 2012 Apr 17.
PubMed 22521351Yap 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 10.
PubMed 27876501Barreto R, Elia C, Sola E, Moreira R, Ariza X, Rodriguez E, Graupera I, Alfaro I, Morales-Ruiz M, Poch E, Guevara M, Fernandez J, Jimenez W, Arroyo V, Gines P. Urinary neutrophil gelatinase-associated lipocalin predicts kidney outcome and death in patients with cirrhosis and bacterial infections. J Hepatol. 2014 Jul;61(1):35-42. doi: 10.1016/j.jhep.2014.02.023. Epub 2014 Mar 5.
PubMed 24613364Angeli P, Gines 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: revised consensus recommendations of the International Club of Ascites. J Hepatol. 2015 Apr;62(4):968-74. doi: 10.1016/j.jhep.2014.12.029. Epub 2015 Jan 28. No abstract available.
PubMed 25638527
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Biomarkers for the Prediction of Response to Terlipressin and Survival in Cirrhotic Patients With Acute Kidney Injury: Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03530761
- Acronym / sponsor ID
- P-KAKI
- Conditions
- Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 May 2018 (actual)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
Key inclusion criteria (2 listed)
- Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
- Patients who voluntarily agreed to the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Transplantation free survival
Time frame: up to 3 years
Regression of acute kidney injury
Time frame: up to 1 month
Recurrence of acute kidney injury
Time frame: up to 1 year
Progression to chronic kidney disease
Time frame: 1 year
Response rate to terlipressin
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Results publication: PubMed 27475248Helmersson-Karlqvist J, Arnlov 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.
- Results publication: PubMed 26042740Ariza X, Sola E, Elia C, Barreto R, Moreira R, Morales-Ruiz M, Graupera I, Rodriguez E, Huelin P, Sole C, Fernandez J, Jimenez W, Arroyo V, Gines P. Analysis of a urinary biomarker panel for clinical outcomes assessment in cirrhosis. PLoS One. 2015 Jun 4;10(6):e0128145. doi: 10.1371/journal.pone.0128145. eCollection 2015.
- Results publication: PubMed 26141259Angeli 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.
- Results publication: PubMed 24700173Wong 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. No abstract available.
- Results publication: PubMed 26484442Wong 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.
- Results publication: PubMed 29369449Jaques 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). 2019 Feb;24(2):170-180. doi: 10.1111/nep.13226.
- Results publication: PubMed 24375576Belcher 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. 2014 Aug;60(2):622-32. doi: 10.1002/hep.26980. Epub 2014 Jun 26.
- Results publication: PubMed 25183658Belcher 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):1857-67. doi: 10.2215/CJN.09430913. Epub 2014 Sep 2.
- Results publication: PubMed 22521351Fagundes C, Pepin MN, Guevara M, Barreto R, Casals G, Sola E, Pereira G, Rodriguez E, Garcia E, Prado V, Poch E, Jimenez W, Fernandez J, Arroyo V, Gines P. Urinary neutrophil gelatinase-associated lipocalin as biomarker in the differential diagnosis of impairment of kidney function in cirrhosis. J Hepatol. 2012 Aug;57(2):267-73. doi: 10.1016/j.jhep.2012.03.015. Epub 2012 Apr 17.
- Results publication: PubMed 27876501Yap 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 10.
- Results publication: PubMed 24613364Barreto R, Elia C, Sola E, Moreira R, Ariza X, Rodriguez E, Graupera I, Alfaro I, Morales-Ruiz M, Poch E, Guevara M, Fernandez J, Jimenez W, Arroyo V, Gines P. Urinary neutrophil gelatinase-associated lipocalin predicts kidney outcome and death in patients with cirrhosis and bacterial infections. J Hepatol. 2014 Jul;61(1):35-42. doi: 10.1016/j.jhep.2014.02.023. Epub 2014 Mar 5.
- Results publication: PubMed 25638527Angeli P, Gines 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: revised consensus recommendations of the International Club of Ascites. J Hepatol. 2015 Apr;62(4):968-74. doi: 10.1016/j.jhep.2014.12.029. Epub 2015 Jan 28. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Jeong-Ju Yoo, Doctor principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Acute Kidney Injury, run by Soonchunhyang University Hospital at 1 site in South Korea.
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 2 inclusion and 6 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 21 May 2018. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Jeong-Ju Yoo, Doctor (82-10-9676-3128, puby17@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 3 years). 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 NCT03530761, which also lists 12 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 21 May 2018.