UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000238 |
|---|---|
| Receipt number | R000000299 |
| Scientific Title | OmX: Peritoneal dilaysis treatment once daily for chronic renal failure -Clinically controlled trial using icodextrin and dextrose solution. |
| Date of disclosure of the study information | 2007/12/31 |
| Last modified on | 2005/09/14 23:06:11 |
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Basic information
Public title
OmX: Peritoneal dilaysis treatment once daily for chronic renal failure -Clinically controlled trial using icodextrin and dextrose solution.
Acronym
OmX
Scientific Title
OmX: Peritoneal dilaysis treatment once daily for chronic renal failure -Clinically controlled trial using icodextrin and dextrose solution.
Scientific Title:Acronym
OmX
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether once daily treatment using post-marketing peritoneal dialysis solutions- dianeal and extraneal- on patients with chronic renal failure requiring dialysis treatment is beneficial or not.
Because the load on the patient in once daily peritoneal dialysis treatment is less and it contributes to a dramatic reuction in medical costs, by clarifying which peritoneal dialysis solution should be chosen and possibilities for this treatment method, it will be possible to obtain beneficial and safe guidelines for this treatment. This trial was therefore deemed necessary and thus planned.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Renal creatinine clearance
Key secondary outcomes
Technical survival (period until use of another dialysis solution)
Renal creatinine clearance variation rate
99mTcDTPA-GFR
QOL and SGA
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
YES
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group using icodextrin, will commence with one 2L bag/day. Additional bags will be added in order to maintain the renal function value at the start date.
Interventions/Control_2
Group using dextrose solution, will commence with one 2L bag/day. Additional bags will be added in order to maintain the renal function value at the start date.
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.Chronic renal failure requiring dialysis treatment. Creatinine clearance less than or equal to 10mL/min.
2. Patients aged between 20-80 years at the time of obtaining consent
3. Patients who provide their written consent of their own free will after receiving and fully comprehending a detailed explanation concerning participation in the trial
Key exclusion criteria
1.Schizophrenia
2.Alzheimer's disease
3.Multiple cerebral infarction, dementia
4.Women who are pregnant or may become pregnant
5.Other patients that the doctor in charge of the trial (assistant doctor) judges to be unsuitable, such as conditions that require emergencey treatment such as cardiac insufficiency and pulmonary congestion.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Renjiro Kuriyama |
Organization
Ohme Municipal General Hospital
Division name
Medical Nephrology
Zip code
Address
Higashi-ohme 4-16-5 Ohme Tokyo 198-0042
TEL
0428223191
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Renjiro Kuriyama |
Organization
Ohme Municipal General Hospital
Division name
Medical Nephrology
Zip code
Address
Higashi-ohme 4-16-5 Ohme Tokyo
TEL
0428-22-3191
Homepage URL
kuriyama-npr@umin.ac.jp
Sponsor or person
Institute
Ohme Municipal General Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical Nephrology, Ohme Municipal General Hospital
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 12 | Month | 31 | 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
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 14 | Day |
Last modified on
| 2005 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000299
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| Registered date | File name |
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