UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023794
Receipt No. 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 (Ver. 7)

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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
Email 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
Email yhamasaki-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo 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 Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-Ku, Tokyo
Tel 03-5841-0818
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027368