UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial comparing renoprotective effect of conventional diuretics (furocemide and potassium canrenoate) with carperitide and conventional diuretics alone in liver transplant recipients.
Acronym	A randomized controlled trial evaluating the renoprotective effect of carperitide in liver transplant recipients.
Scientific Title	A randomized controlled trial comparing renoprotective effect of conventional diuretics (furocemide and potassium canrenoate) with carperitide and conventional diuretics alone in liver transplant recipients.
Scientific Title:Acronym	A randomized controlled trial evaluating the renoprotective effect of carperitide in liver transplant recipients.
Region	Japan

Condition
Condition	liver transplantation recipients
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the renoprotective effect of conventional diuretics (furosemide and pottassium canrenoate) combined with carperitide (hANP), and conventional diuretics alone in patients with renal insufficiency after liver transplantation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The number (rate) of cases requiring induction of hemo-dialysis due to insufficient diuresis fulfilling the following criteria. 1)Serum creatinine of >6.0mg/dl 2)Oliguria(1ml/kg/hr)lasting over 6hours 3)Serum potassium of > 6.0mEq/l
Key secondary outcomes	1)Body weight 2)Blood pressure, pulse rate, urine volume 3)Serum creatinine, urea nitrogen 4)Serum atrial natriuretic peptide, aldosterone, brain natriuretic peptide, cyclic GMP 5)Serum renin activity 6)Urine creatinine 7)Urine NAG 8)Urine L-FABP 9)creatinine clearance

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of carperitide by the central dose of 0.1ug/kg/min, which is modulated between 0.025 and 0.22ug/kg/min according to the reactive urination.
Interventions/Control_2	Dose up of conventional diuretics(flosemide; up to 2mg/kg/day, pottassium canrenoate; up to 8mg/kg/day ) alone.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient selection: Patients who present with the following findings despite the use of conventional diuretics (furocemide up to 0.4mg/kg/day and potassium canrenoate up to 4mg/kg/day) among those who fulfill the above conditions and agreed to participate; A.) Elevated serum creatinine more than oe equal to 1mg/dl compared to that of preoperative value. B.) Oliguria less than or equal to 1ml/kg/h within 3 days postoperatively (evaluated q6 hours).
Key exclusion criteria	Exclusion criteria 1) Patients on chronic hemo-dialysis. 2) Patients who required hemo-dialysis prior to transplantation. (Includes the use of continuous hemo-diafiltration for treating hepatic coma in fulminant hepatic failure) 3) Patients with underlying complications such as diabetes, hypertension, heart disease, hepatopulmonary syndrome, pulmonary hypertension etc. 4) Patients with renal disease other than hepatorenal syndrome. 5) Patients with contraindicated conditions for the use of studied agent such as pheochromocytoma, epilepsy, and right ventricle infarction. 6) Those that are considered ineligible by the participating physician.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiko Sugawara
Organization	University of Tokyo
Division name	Artificial Organ and Transplantation Division, Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL	+81-3-3815-5411
Email	yasusuga-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuhiko Sugawara
Organization	University of Tokyo
Division name	Artificial Organ and Transplantation Division, Hepato-Biliary-Pancreatic Surgery Division, Departme
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL	03-3815-5411
Homepage URL
Email	yasusuga-tky@umin.ac.jp

Sponsor
Institute	The Artificial Organ and Transplantation Division, Department of Surgery
Institute
Department

Funding Source
Organization	The Artificial Organ and Transplantation Division, Department of Surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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IRB Contact (For public release)
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Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2006 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date	2005 Year 12 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
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Other
Other related information

Management information
Registered date	2006 Year 02 Month 08 Day
Last modified on	2015 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000374

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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