UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006611 |
|---|---|
| Receipt number | 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 13:55:37 |
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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
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
hkomaba@tokai-u.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006606
