UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037470 |
|---|---|
| Receipt number | R000042699 |
| Scientific Title | Retrospective observational study on efficacy, safety and adherence of suclooxyhydroxide granules |
| Date of disclosure of the study information | 2019/07/24 |
| Last modified on | 2020/08/24 13:35:20 |
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Basic information
Public title
Retrospective observational study on efficacy, safety and adherence of suclooxyhydroxide granules
Acronym
P-TOL-R
Scientific Title
Retrospective observational study on efficacy, safety and adherence of suclooxyhydroxide granules
Scientific Title:Acronym
P-TOL-R
Region
| Japan |
Condition
Condition
Chronic maintenance dialysis patient
Hyperphosphatemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A retrospective survey will be conducted on patients who took P-TOL chewable tablets and granules, including the feeling of taking and adherence to medication, the usage status and clinical laboratory values of concomitant medications after using preparations.
Basic objectives2
Others
Basic objectives -Others
We examine the usefulness and safety of changing to granular formulations.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
For over 3 months, take over the P-TOL Chewable Tablet and switch to the P-TOL Granules for over 3 months
When it passed
Questionnaire survey on adherence
Key secondary outcomes
For over 3 months, take over the P-TOL Chewable Tablet and switch to P-TOL Granules for over 3 months
When it passed
･Change of concomitant medication
･Changes in laboratory test values (phosphorus)
･Safety evaluation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Patients who obtained written consent
･Patients who have hyperphosphatemia in chronic maintenance dialysis patients
･Patients receiving stable hemodialysis three or more times a week
･P-TOL chewable tablets for 3 months or more, and patients who have been switched to P-TOL granules for 3 months or more
･Outpatient
･Patients over 20 years old
･Gender does not matter
Key exclusion criteria
･Patients who underwent parathyroidectomy (PTX) during the period of taking P-TOL Chewable Tablets or P-TOL granules
･Patients who are considered inappropriate for the clinical research by the principal investigator or co-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Isaka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Nephrology
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka,565-0871,Japan
TEL
06-6879-3857
isaka@kid.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Akiyama |
Organization
The Japan Clinical Research Forum
Division name
Secretariat
Zip code
532-0004
Address
1-8-29 NIshimiyahara, Yodogawa-ku, Osaka-City,532-0004,Japan
TEL
06-6398-5192
Homepage URL
P-TOL-R@jarf.or.jp
Sponsor or person
Institute
Kissei Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University School of Medicine Hospital Observation Research Ethics Review Committee
Address
1-8-29 NIshimiyahara, Yodogawa-ku, Osaka-City,532-0004,Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.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
1.社会医療法人 愛仁会 井上病院（大阪）
2.医療法人 淳康会 堺近森病院（大阪）
3.医療法人 西診療所（大阪）
4.社会医療法人純幸会 関西メディカル病院附属 豊中渡辺クリニック（大阪）
5.特定医療法人紀陽会 長居クリニック（大阪）
6.社会医療法人 彩樹 門真けいじん会クリニック（大阪）
7.医療法人徳靖会 小尾クリニック（大阪）
8.医療法人 谷口クリニック（大阪）
9.医療法人医誠会 城東医誠会クリニック（大阪）
10.医療法人好輝会 梶本クリニック（大阪）
11.医療法人桜希会 東朋八尾病院（大阪）
12.社会医療法人 彩樹 豊中けいじん会クリニック（大阪）
13.医療法人育祥会 須澤クリニック（大阪）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 24 | 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
94
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 28 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 06 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 20 | Day |
Other
Other related information
All investigators responsible for the research and all persons involved in the research leak personal information, etc., which is held by the medical institution to which the researcher belongs (including when entrusted and stored). It must be properly handled to prevent loss or damage or for other safety management.
The research investigator and all persons involved in the research should ensure that all information obtained in the research can not be used to identify an individual by using the study subject identification number.
When the research investigator and all persons involved in the research are to publish the results of the research, do not include any information that can identify the research subject.
The research investigator and all those involved in the study should carefully handle and store the data obtained in the study and do not make secondary use.
The research investigator and all persons involved in the research shall prepare and keep records on provision of information at the source organization and destination organization at the time of third party provision from the viewpoint of securing traceability of personal information.
The sponsor, the contract research institutes, the research representatives and the heads of medical institutions each conclude a written contract agreement on matters to be observed (including the contents of safety management). In addition, the sponsor performs necessary and appropriate supervision (for example, confirmation of compliance with safety management, etc.) on the contractor.
Management information
Registered date
| 2019 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042699
| Research Plan | |
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| Registered date | File name |
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