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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000238
Receipt No. 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

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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
Email

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
Email kuriyama-npr@umin.ac.jp

Sponsor
Institute Ohme Municipal General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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