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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037470
Receipt No. 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 2020/01/27

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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
Email 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
Email P-TOL-R@jarf.or.jp

Sponsor
Institute Kissei Pharmaceutical Co., Ltd.
Institute
Department

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
Email 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
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042699

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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