UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035414 |
|---|---|
| Receipt number | R000040349 |
| Scientific Title | The effect of calcimimetics on complications of chronic kidney disease |
| Date of disclosure of the study information | 2018/12/30 |
| Last modified on | 2024/02/15 16:24:25 |
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Basic information
Public title
The effect of calcimimetics on complications of chronic kidney disease
Acronym
The effect of calcimimetics on complications of chronic kidney disease
Scientific Title
The effect of calcimimetics on complications of chronic kidney disease
Scientific Title:Acronym
The effect of calcimimetics on complications of chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease(CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of calcimimetics on complications of CKD patients (e.g., bone and mineral metabolism factor, bone mineral density, parathyroid enlargement, left ventricular hypertrophy)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of the effect of calcimimetics on bone and mineral metabolism factor, bone density, parathyroid enlargement in CKD patients
Key secondary outcomes
Effects of calcimimetics on cardiac function and bone metabolism markers in CKD patients
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients who are visiting our hospital regularly
Key exclusion criteria
Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Division of Nephrology
Zip code
339-0012
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL
0487921811
kuwahara@k-naika-cl.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Division of Nephrology
Zip code
339-0012
Address
366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL
0487921811
Homepage URL
kuwahara@k-naika-cl.jp
Sponsor or person
Institute
Saitama Tsukinomori Clinic
Institute
Department
Personal name
Funding Source
Organization
Saitama Tsukinomori Clinic
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
The Ethics Committee of Saitama Tsukinomori Clinic
Address
366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
Tel
0487921811
hayama@k-naika-cl.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 30 | 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
32
Results
Etelcalcetide was administered to 32 hemodialysis patients with secondary hyperparathyroidism. iPTH, BAP, Osteocalcin, TRACP 5b, and FGF23 decreased significantly, and this decrease persisted.
Results date posted
| 2024 | Year | 02 | Month | 15 | Day |
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
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 15 | Day |
Other
Other related information
This is an observational study. Of the patients who visited the division of nephrology of the Tsukinomori clinic, all patients fulfilling the selection criteria are targeted.
Management information
Registered date
| 2018 | Year | 12 | Month | 30 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040349
