UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023794 |
|---|---|
| Receipt number | R000027368 |
| Scientific Title | An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in peritoneal dialysis patients |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2019/08/31 16:08:18 |
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Basic information
Public title
An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in peritoneal dialysis patients
Acronym
An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in PD patients
Scientific Title
An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in peritoneal dialysis patients
Scientific Title:Acronym
An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in PD patients
Region
| Japan |
Condition
Condition
Peritoneal dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pyridoxamine is known as an agent reducing carbonyl stress which causes peritoneal injury in peritoneal dialysis (PD). The clinical pharmacokinetics and efficacy of pyridoxamine in PD patients are still unclear. In this study, we will evaluate the pharmacokinetics, efficacy and safety of pyridoxamine in stable PD patients.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of blood concentration of pyridoxamine until 6 month after starting administration of pyridoxamine.
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 (200mg t.i.d) pyridoxamine for 182 days (6months)
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
1) Starble PD more than 3months after starting PD.
2) Written informed concent from the patient.
3) More than 20 years old and less than 80 years old.
4) Without taking vitamin B6 (cessation more than 4 weeks ago).
Key exclusion criteria
1) Combined therapy with PD and hemodialysis.
2) Severe liver disease.
3) Previous severe adverse effect and allergy.
4) Participating other clinical studies.
5) Malignancy, or less than 3 years after treatment of the cancer.
6) Less than 6 months from previous cardiovascular disease (myocardial infarction and apoplexy).
7) More than 8 years PD, or having encapsulating peritoneal sclerosis.
8) Peripheral arterial disease (more than class 2 of Fontaine classification).
9) Uncontrolled hypertension (more than 180mmHg of systolic BP and 120mmHg of diastolic BP).
10) HbA1c >8.0%.
11) Severe anemia (Hb <9.0g/dl)
12) Using aminophylline, theophylline, cholinetheophylline, levodopa, pyridoxal, pyridoxine, and other vitamin B6 agents within 4 weeks.
13) Expected pregnancy within 1 year.
14) Others judged to be excluded by doctors.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Masaomi |
| Middle name | |
| Last name | Nangaku |
Organization
The University of Tokyo Hospital
Division name
Department of Nephrology and Endocrinology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
mnangaku-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Hamasaki |
Organization
The University of Tokyo Hospital
Division name
Department of Hemodialysis and Apheresis
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yhamasaki-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo 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
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
https://u-tokyo.bvits.com
Publication of results
Unpublished
Result
URL related to results and publications
https://u-tokyo.bvits.com
Number of participants that the trial has enrolled
6
Results
Since it was difficult to measure pyridoxamine concentration, we reported the results of analysis of data other than pyridoxamine at a meeting for investigators of pyridoxamine in dialysis patients.
Results date posted
| 2019 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
male:5, female:1
age(ave.):63.4
Cause of ESRD; CGN:3, DMN:1, others:2
PD duration(ave): 27 months
Participant flow
6 PD patients who have given informed consent in the document, took pyridoxamine (600mg/day) for 6 months.
Blood was collected every month for a half year, and a total of three PD effluent examination and Peritoneal equilibration test were performed.
Adverse events
In one patient (5 months after starting pyridoxamine), CAPD catheter exit site/ tunnel infection was occured. Improvement was achieved by antibacterial treatment and change of exit site by surgery.
Outcome measures
Blood: TP, Alb, GOT, GPT, gamma-GTP, ALP, P, Ca, Na, K, Cl, CRP, CK, total cholesterol, LDL-C, HDL-C, TG, BNP, i-PTH, beta 2 microglobulin(BMG)
PD effluent: ultrafiltration volume, pKt/V, BMG, protein loss
Urine: Urine volume, NAG, BMG, rKt/V, L-FABP
Peritoneal equilibrium test: D/Pcre
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027368
