UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011673
Receipt No. R000013648
Scientific Title The safety of novel gut peptide ghrelin for the treatment of chronic kidney disease
Date of disclosure of the study information 2013/09/10
Last modified on 2013/09/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The safety of novel gut peptide ghrelin for the treatment of chronic kidney disease
Acronym The safety ofghrelin
Scientific Title The safety of novel gut peptide ghrelin for the treatment of chronic kidney disease
Scientific Title:Acronym The safety ofghrelin
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the novel therapeutic strategy against chronic kidney disease, we test the safety of administration of a novel gut peptide ghrelin.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes The temporal change of plasma concentration of ghrelin after the iv infusion
Key secondary outcomes Change of eGFR
Anthropodic change
Renal function
Metabolic marker
Oxidative stressmarker
Nutrition status
Adverse effects by ghrelin infusion

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are 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 ghrelin
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age over 20 years old
2. CKD patients at the stage, G3 and G4
3. BMI under 25
4. the patients that can cooperate with our study
Key exclusion criteria 1. subjects with severe liver dysfunction
2. subjects with neoplasma
3. subjects with severe infection
4. subjects with psychogenic disorder
5. sujects with allergic reaction to wheat, egg, and milk
6. pregnant women
7. subjects tha were not egligble for the stusy
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Itoh
Organization Keio University, Scool of Medicine
Division name Division of nephrology, endocrinology, and metabolism
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email hiito@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shu Wakino
Organization Keio University, Scool of Medicine
Division name Division of nephrology, endocrinology, and metabolism
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email shuwakino@z8.keio.jp

Sponsor
Institute Keio University, Scool of Medicine, Division of nephrology, endocrinology, and metabolism
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2013 Year 09 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 Preinitiation
Date of protocol fixation
2013 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 20 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
2013 Year 09 Month 06 Day
Last modified on
2013 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013648


Contact us.