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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002769
Receipt No. R000003359
Scientific Title Evaluation of cinacalcet on clinical outcome depending on serum PTH level in Japanese patients with SHPT:ECO study
Date of disclosure of the study information 2009/11/18
Last modified on 2011/11/16

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Basic information
Public title Evaluation of cinacalcet on clinical outcome depending on serum PTH level in Japanese patients with SHPT:ECO study
Acronym Evaluation of cinacalcet on clinical outcome for in Japanese patients with SHPT:ECO study
Scientific Title Evaluation of cinacalcet on clinical outcome depending on serum PTH level in Japanese patients with SHPT:ECO study
Scientific Title:Acronym Evaluation of cinacalcet on clinical outcome for in Japanese patients with SHPT:ECO study
Region
Japan

Condition
Condition Secondary hyperparathyroidism
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 estimate the impact of clinical outcome depending on serum PTH level in Japanese patients with SHPT
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the proportion of patients who achieve JSDT guideline targets
Key secondary outcomes

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 administration of Cinacalcet HCl
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects were eligible for the study if they met the following criteria:

1. intact PTH over 180 pg/ml and Ca over 9.0mg/dl and P over 3.5mg/dl
2. intact PTH from 60 to 180pg/ml over Ca 10.0mg/dl and P 3.5mg/dl
or intact PTH from 60 to 180pg/ml over Ca 9.0mg/dl and P 6.0mg/dl
Key exclusion criteria 1. pregnant woman
2.received therapy with bisphosphonate within 24 weeks before IC
3.received therapy with estrogen hormone when signed IC
4.severe hepatic dysfunction or cirrhosis
5. drug allergies
6. malignancy
7. unsuitable patients
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Hosoya
Organization The Jikei University School of Medicine
Division name Division of Kidney and Hypertension, Department of Internal Medicine
Zip code
Address 3-19-18, Nishi-Shimbashi, Minato-ku,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keitaro Yokoyama
Organization The Jikei University School of Medicine
Division name Division of Kidney and Hypertension, Department of Internal Medicine
Zip code
Address 3-19-18, Nishi-Shimbashi, Minato-ku,Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Division of Kidney and Hypertension, Department of Internal Medicine,The Jikei University School of Medicine
Institute
Department

Funding Source
Organization none
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
2009 Year 11 Month 18 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
2008 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2010 Year 03 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
2009 Year 11 Month 16 Day
Last modified on
2011 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003359

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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