UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028485 |
|---|---|
| Receipt number | 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 08:42:36 |
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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
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
handahiroshi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006662
