UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001379 |
|---|---|
| Receipt number | R000001677 |
| Scientific Title | Prospective randomized controlled study for the therapeutic effect of removing uremic toxins on endothelial function in undialyzed patients with chronic renal failure |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2011/03/17 12:53:44 |
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Basic information
Public title
Prospective randomized controlled study for the therapeutic effect of removing uremic toxins on endothelial function in undialyzed patients with chronic renal failure
Acronym
Effect of removing uremic toxins on endothelial function
Scientific Title
Prospective randomized controlled study for the therapeutic effect of removing uremic toxins on endothelial function in undialyzed patients with chronic renal failure
Scientific Title:Acronym
Effect of removing uremic toxins on endothelial function
Region
| Japan |
Condition
Condition
Undialyzed patients with chronic renal failure
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the therapeutic effect of removing uremic toxins by oral adsorbent AST-120 on endothelial function in undialyzed patients with chronic renal failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow-mediated vasodilation of branchial artery
Key secondary outcomes
Changes of the below parameters:
(1) Systolic and diastolic blood pressure
(2) Creatinine clearance (Ccr)
(3) Urinary protein excretion (UPE)
(4) Mediators associated with endothelial function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treated by AST-120 6g daily for a period of 6 months
Interventions/Control_2
Not treated by AST-120 for a period of 6 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Medications have not been changed in the last 6 months.
(2) Blood pressures have been controlled appropriately in the last 6 months.
(3) HbA1c levels have been stable within +/-0.5% changes in the last 6 months.
(4) Over 20 years of age.
(5) Patients with the informed consent to this study.
Key exclusion criteria
(1) Patients with obstructive or stenotic diseases of digestive organs.
(2) Patients with the nephrotic syndrome.
(3) Patients with acute renal failure, rapid elevation of serum creatinine or active nephropahty in the last 6 months.
(4) Patients with inflammatory or consumptive diseases (e.g. infection, malignancy).
(5) Patients with severe cardiovascular diseases (e.g. heart failure, coronary disease, cerebrovascular disease, peripheral vascular disease).
(6) Dialyzed patients.
(7) Patients treated by AST-120.
(8) Patients treated by steroids or immunosuppressive agents.
(9) Females in pregnancy.
(10) Patients judged as unsuitable for participating in this study by the attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Komai |
Organization
Kawasaki Medical School
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Nishi |
Organization
Kawasaki Medical School
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
Homepage URL
yuko-n77@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Division of Nephrology, Department of Internal Medicine, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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 | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | 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 | 09 | Month | 17 | Day |
Last modified on
| 2011 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001677
