UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031730 |
|---|---|
| Receipt number | 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 17:50:26 |
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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
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
chieko@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028443
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
