UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001040 |
|---|---|
| Receipt number | R000000421 |
| Scientific Title | Randomized Trial of Icodextrin and Glucose Dialysate in CAPD Patients with Diabetic Nephropathy |
| Date of disclosure of the study information | 2008/02/18 |
| Last modified on | 2017/08/26 09:24:17 |
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Basic information
Public title
Randomized Trial of Icodextrin and Glucose Dialysate in CAPD Patients with Diabetic Nephropathy
Acronym
Extraneal Study
Scientific Title
Randomized Trial of Icodextrin and Glucose Dialysate in CAPD Patients with Diabetic Nephropathy
Scientific Title:Acronym
Extraneal Study
Region
| Japan |
Condition
Condition
Patients with end-stage renal disease caused by diabetic nephropathy, who have 10 years history of diabetes and diabetic retinopathy.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this clinical study is to compare two ESRD groups newly introduced to CAPD therapy. ESRD patients are randomly assigned to Dianeal group treated with conventional glucose dialysate only and Extraneal group tretaed with Dianyl and Icodextrin dialysate. In a prospective clinical study with two-year observation, we compare the drop out rate of the CAPD therapy and the residual renal function .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Drop out rate of CAPD therapy
Key secondary outcomes
Residual renal function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1:The group treated with glucose dialysis solution.
Interventions/Control_2
Group2:The group treated with Icodextrin dialysis solution and glucose dialysis solution.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients newly treated with peritoneum dialysis (including CAPD and APD) as renal replacement therapy. Patinets, who introduced to PD therapy after the treatment with temporaly mergency HD and an ECUM.
Key exclusion criteria
1. Urine volume less than 400 ml.
2. Urinaly tract obstruction caused by renal stones, tumors, trauma, and neuronal bladder)
3. Pregnancy
4. Patients treated with PD, HD, or transplantaion for more than 3 months.
5. Patients, who are younger than 18 years and older than 80 yeras.
6. Contraindication (allergic) to Extraneal.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Wada |
Organization
Okayama University Graduate School of Medicine
Division name
Department of Medicine and Clinical Science
Zip code
Address
Shikata-cho,Okayama-city,Okayama
TEL
0862357232
junwada@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Wada |
Organization
Okayama University Graduate School of Medicine
Division name
Department of Medicine and Clinical Science
Zip code
Address
Shikata-cho,Okayama-city,Okayama
TEL
0862357232
Homepage URL
junwada@okayama-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine
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
| 2008 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://cjasn.asnjournals.org/content/6/6/1337.long
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
| 2005 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2010 | Year | 04 | 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 | 02 | Month | 18 | Day |
Last modified on
| 2017 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000421
