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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006611
Receipt No. R000006606
Scientific Title Effect of parathyroidectomy on serum Klotho and FGF23 levels in hemodialysis patients with severe secondary hyperparathyroidism
Date of disclosure of the study information 2011/11/01
Last modified on 2014/04/25

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Basic information
Public title Effect of parathyroidectomy on serum Klotho and FGF23 levels in hemodialysis patients with severe secondary hyperparathyroidism
Acronym Klotho-PTx study
Scientific Title Effect of parathyroidectomy on serum Klotho and FGF23 levels in hemodialysis patients with severe secondary hyperparathyroidism
Scientific Title:Acronym Klotho-PTx study
Region
Japan

Condition
Condition Secondary hyperparathyroidism
Classification by specialty
Endocrinology and Metabolism Nephrology Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of parathyroidectomy on serum Klotho and FGF23 levels in hemodialysis patients with severe secondary hyperparathyroidism
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assess the effects on parathyroidectomy on serum Klotho and FGF23 levels
Key secondary outcomes Changes from baseline in serum calcium, phosphorus, and intact PTH levels

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
Maneuver
Interventions/Control_1 Parathyroidectomy
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 Serum intact PTH >500pg/ml
Serum calcium >10.0mg/dl or phosphorus >6.0mg/dl
Presence of enlarged parathyroid glands larger than 500mm3
Key exclusion criteria Dialysis vintage less than 3 months
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Kakuta
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL 0463-93-1121
Email kakuta@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotaka Komaba
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
Address 143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL 0463-93-1121
Homepage URL
Email hkomaba@tokai-u.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Jinken Clinic
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
2011 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 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
2011 Year 10 Month 25 Day
Last modified on
2014 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006606

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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