UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000329
Receipt number R000000374
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.
Date of disclosure of the study information 2006/02/10
Last modified on 2015/08/08 09:23:52

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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 or person

Institute

The Artificial Organ and Transplantation Division, Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

The Artificial Organ and Transplantation Division, Department of Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


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


Date analysis concluded



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000374


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name