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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031730
Receipt No. R000028443
Scientific Title Effects of pyridoxamine for peritoneal injury in patients with peritoneal dialysis: Search of the effective end-point
Date of disclosure of the study information 2018/03/15
Last modified on 2018/03/14

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Basic information
Public title Effects of pyridoxamine for peritoneal injury in patients with peritoneal dialysis: Search of the effective end-point
Acronym PYDinPD-S
Scientific Title Effects of pyridoxamine for peritoneal injury in patients with peritoneal dialysis: Search of the effective end-point
Scientific Title:Acronym PYDinPD-S
Region
Japan

Condition
Condition Peritoneal Injury in patients with peritoneal dialysis
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Search of of the effective non-invasive surrogate markers for peritoneal injury
Basic objectives2 Others
Basic objectives -Others Search of the change factors in before and after pyridoxamine administration
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of D/P creatinine and ultrafiltration rate in peritoneal equilibrium test and net ultrafiltraion volume in 24-hours 3 months after pyridoxamine administration. Changes of pyridoxamine, pyridoxal and pyridoxine in peritoneal effluent and sera 3 months after pyridoxamine administration.
Key secondary outcomes

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
Other
Interventions/Control_1 Oral administration of 600mg/day (200mgmg t.i.d) pyridoxamine for 6 months
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
80 years-old >
Gender Male and Female
Key inclusion criteria Stablr PD more than 3months after the starting PD
Key exclusion criteria >Combined therapy with PD and hemodialysis
>Severe liver disease
>Previous severe adverse effect and all allergy
>Participating other clinical stadies
>Malignancy, or less than 3-years after treatment of the cancer
>Less than 6-months from previous cardiovascular disease (myocaridial infarction and apoplexy)
>More than 8 years PD, or having enca psulating peritoneal sclerosis.
>Peripheral arterial disease (more than class 2 of Fontaine classification).
>Uncontrolled hypertension (more than 180mmHg of systolic BP and 120mmHg of diastolic BP).
>HbA1c >8.0%.
>Severe anemia (Hb <9.0g/dl)
>Using aminophylline, theophylline, cholinetheophylline, levodopa, pyridoxa l, pyridoxine, and other vitamin B6 agen ts within 4 weeks.
>Expected pregnancy within 1 year.
>Others judged to be excluded by doc tors.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chieko Hamada
Organization Juntendo Hospital
Division name Division of Nephrology
Zip code
Address 2-1-1 Hongo, Bunkyoku, Tokyo
TEL 03-5802-1065
Email chieko@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chieko Hamada
Organization Juntendo Hospital
Division name Division of Nephrology
Zip code
Address 2-1-1 Hongo, Bunkyoku, Tokyo
TEL 03-5802-1065
Homepage URL
Email chieko@juntendo.ac.jp

Sponsor
Institute Juntendo Hospital
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2018 Year 03 Month 15 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
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
2016 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 14 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
2018 Year 03 Month 14 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028443

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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