UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027555 |
|---|---|
| Receipt number | R000031588 |
| Scientific Title | Once-weekly Hemodialysis Combined with Low Protein and Low Salt Dietary Treatment; A Favorable Therapeutic Modality for Selected Patients with End-stage Kidney Disease |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2017/05/30 20:55:33 |
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Basic information
Public title
Once-weekly Hemodialysis Combined with Low Protein and Low Salt Dietary Treatment; A Favorable Therapeutic Modality for Selected Patients with End-stage Kidney Disease
Acronym
Once-weekly Hemodialysis Combined with Dietary Treatment
Scientific Title
Once-weekly Hemodialysis Combined with Low Protein and Low Salt Dietary Treatment; A Favorable Therapeutic Modality for Selected Patients with End-stage Kidney Disease
Scientific Title:Acronym
Once-weekly Hemodialysis Combined with Dietary Treatment
Region
| Japan |
Condition
Condition
End-stage chronic kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess long-term effectiveness of a combined therapy consisting of once-weekly hemodialysis and dietary treatment with a low-protein and a low-salt
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of the treatment for a five-year period
Key secondary outcomes
1.Serial changes in biochemical and clinical parameters(serum urea nitrogen, potasium, phosphate, albumin, body mass index,interdialytic weight gain, etc) until 24 months after beginning of the teatment
2.Time required and cost for medical treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. renal function: creatinine clearance below 5.0 ml/min, 2. clinical symptoms: existence or potential emergence of uremic gastrointestinal symptoms or other uremic symptoms only on conservative treatment, 3. patient's will: well motivated to choice the therapeutic modality,
Key exclusion criteria
no motivation to adhere dietary treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakao |
Organization
Organization for kidney and metabolic disease treatment
Division name
Research department
Zip code
Address
Kubo-builuding 3F, Yoyogi 2-9-2, Shibuya ward, Tokyo
TEL
03-3376-0191
t-nakao@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakao |
Organization
Organization for kidney and metabolic disease treatment
Division name
Research department
Zip code
Address
Kubo-builuding 3F, Yoyogi 2-9-2, Shibuya ward, Tokyo
TEL
03-3376-0191
Homepage URL
t-nakao@tokyo-med.ac.jp
Sponsor or person
Institute
Organization for kidney and metabolic disease treatment
Institute
Department
Personal name
Funding Source
Organization
Organization for kidney and metabolic disease treatment
Organization
Division
Category of Funding Organization
Self funding
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
東京医科大学病院、望星新宿南口クリニック
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 30 | 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
| 1992 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1992 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One-hundred and twelve consecutive patients on the treatment between 1992 and 2014 at Tokyo Medical University Hospital and Bousei Shinjuku-minamiguchi Clinic, and followed until the end of 2016, were enrolled in this study
Management information
Registered date
| 2017 | Year | 05 | Month | 30 | Day |
Last modified on
| 2017 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031588
| 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 |
