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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021580
Receipt No. R000024879
Scientific Title Confirmation of safety of new gastrointestinal peptide Ghrelin in patients with chronic kidney disease
Date of disclosure of the study information 2016/03/23
Last modified on 2019/03/26

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Basic information
Public title Confirmation of safety of new gastrointestinal peptide Ghrelin in patients with chronic kidney disease
Acronym Confirmation of safety of new gastrointestinal peptide Ghrelin in patients with chronic kidney disease
Scientific Title Confirmation of safety of new gastrointestinal peptide Ghrelin in patients with chronic kidney disease
Scientific Title:Acronym Confirmation of safety of new gastrointestinal peptide Ghrelin in patients with chronic kidney disease
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety of new gastrointestinal peptide Ghrelin in patients with chronic kidney disease
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes time course of ghrelin blood concentration
Key secondary outcomes onset rate of any serious adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ghrelim 5microgram/kg body weight
Ghrelim 10microgram/kg body weight
Ghrelim 15microgram/kg body weight
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

Not applicable
Gender Male and Female
Key inclusion criteria patients with chronic kidney disease
eGFR less than 30ml but not on dialysis
BMI less than 25
patients with well understanding of this study and submitting a written IC
Key exclusion criteria patients with severe liver dysfunction
patients with malignant neoplasm
patients with severe infection
patients with psycological problems
patients who have allergy for wheat,milk and egg
patients who plans for pregnancy
who are judged to be inappropriate for the study by the attending physician
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Itoh
Organization School of Medicine Keio University
Division name Nephrology, Endocrinology and Metabolism
Zip code 160-8582
Address 35 Shinanomachi Shinjukuku Tokyo
TEL 03-5363-3796
Email hiito@z8.keio.jp

Public contact
Name of contact person
1st name Shuu
Middle name
Last name Wakino
Organization School of Medicine Keio University
Division name Nephrology, Endocrinology and Metabolism
Zip code 160-8582
Address 35 Shinanomachi Shinjukuku Tokyo
TEL 03-5363-3796
Homepage URL
Email shuwakino@z8.keio.jp

Sponsor
Institute Division of Nephrology, Endocrinology and Metabolism School of Medicine Keio University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization School of Medicine Keio University
Address 35 Shinanomachi Shinjikuku
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.ac.jp

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 23 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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 16 Day
Date of IRB
2015 Year 12 Month 16 Day
Anticipated trial start date
2015 Year 12 Month 16 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 23 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024879

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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