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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028485
Receipt No. R000006662
Scientific Title A phase 2 study of carperitide for kidney injury associated with allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2017/08/30
Last modified on 2017/08/02

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Basic information
Public title A phase 2 study of carperitide for kidney injury associated with allogeneic hematopoietic stem cell transplantation
Acronym Carperitide trial for hematopoietic stem cell transplantation
Scientific Title A phase 2 study of carperitide for kidney injury associated with allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Carperitide trial for hematopoietic stem cell transplantation
Region
Japan

Condition
Condition allogeneic hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to clarify the efficacy and safety of carperitide on kidney injury associated with allogeneic stem cell transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes serum creatinin at day 4
Key secondary outcomes CCr
Urine volume
BUN
Urine midkine, N-gal

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carperitide treatment
Interventions/Control_2
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1.Recipients of hematopoietic stem cell transplantation
2.meet eligibility criteria of the normal hematopoietic stem cells transplantation
3.do not have any severe organ damage
4.agreement is provided in a document
Key exclusion criteria 1. Contraindicated] in the patient [attachment document with serious low blood pressure or the cardiogenic shock
2. Contraindicated] in the patient [attachment document with the RV myocardial infarction
3. Contraindicated] in the patient [attachment document with the dehydration
6. Chronic dialysis patient
7.ACE inhibitor, ARB treatment started within two weeks
8.patient received contrast media within three days
10,The patient who is inappropriate judged by the chief physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Handa, Hiroshi
Organization Gunma University, Graduate School of Medicine
Division name Medicine and Clinical Science
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma
TEL 027-220-8166
Email handahiroshi@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Handa, Hiroshi
Organization Gunma University, Graduate School of Medicine
Division name Medicine and Clinical Science
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma
TEL 0272208166
Homepage URL
Email handahiroshi@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
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 群馬大学医学部附属病院 血液内科

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 30 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
2010 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 01 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006662

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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