UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001287 |
|---|---|
| Receipt number | R000001569 |
| Scientific Title | Prevention of dialysate-induced peritoneal damage by pyridoxal phosphate |
| Date of disclosure of the study information | 2008/08/04 |
| Last modified on | 2009/02/10 18:32:30 |
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Basic information
Public title
Prevention of dialysate-induced peritoneal damage by pyridoxal phosphate
Acronym
Prevention of dialysate-induced peritoneal damage by pyridoxal phosphate
Scientific Title
Prevention of dialysate-induced peritoneal damage by pyridoxal phosphate
Scientific Title:Acronym
Prevention of dialysate-induced peritoneal damage by pyridoxal phosphate
Region
| Japan |
Condition
Condition
Patients with end-stage renal disease on peritoneal dialysis
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Progression of peritoneal damage created by injection of glucose-based dialysate into rat peritoneal cavity is prevented by simultaneous injection of PLP solution. The aim of present study is to identify if oral administration of PLP would also protect human peritoneum from the toxicity of glucose-based dialysate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
After starting PLP treatment, the concentrations of growth factors, chemical mediators and AGE in used dialysate will be regularly measured and those indices will be compared between dialysate before and after PLP treatment.
Key secondary outcomes
An appropriate daily dosage of PLP will be determined.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group I; Patients treated with glucose-based dialysate, to whom PLP is not given (n=20).
Interventions/Control_2
Group II; Patients treated with glucose-based dialysate, to whom PLP is given (300mg/day, n=20)
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Patients who are aged above 18
2, Patients with chronic renal failure on peritoneal dialysis
3, Fully informed consent should be obtained
Key exclusion criteria
1, Patients with heart failure of NYHAIII and IV
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakurako Nakamura |
Organization
Miyanomori Memorial Hospital
Division name
Clinical nephrology
Zip code
Address
3-7-5-25 Miyanomori, Chuou-ku, Sapporo 064-8570, Japan
TEL
011-641-6641
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakurako Nakamura |
Organization
Miyanomori Memorial Hospital
Division name
Clinical nephrology
Zip code
Address
3-7-5-25 Miyanomori, Chuou-ku, Sapporo 064-8570, Japan
TEL
011-641-6641
Homepage URL
s.nakamura@miyanomori.or.jp
Sponsor or person
Institute
Miyanomori Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Miyanomori Memorial Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nikko Memorial Hospital
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
| 2008 | Year | 08 | Month | 04 | 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
Date of protocol fixation
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 02 | Day |
Last modified on
| 2009 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001569
