UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010059 |
|---|---|
| Receipt number | R000011775 |
| Scientific Title | Estimating the efficacy of the oral alkalizers in patients with chronic kidney disease. |
| Date of disclosure of the study information | 2013/02/26 |
| Last modified on | 2013/02/19 15:03:08 |
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Basic information
Public title
Estimating the efficacy of the oral alkalizers in patients with chronic kidney disease.
Acronym
Efficacy of the alkalizers on CKD.
(CKOALA study)
Scientific Title
Estimating the efficacy of the oral alkalizers in patients with chronic kidney disease.
Scientific Title:Acronym
Efficacy of the alkalizers on CKD.
(CKOALA study)
Region
| Japan |
Condition
Condition
Chronic kidney disease.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy of oral alkalizers in patients with CKD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum creatinine level, eGFR, protein urea.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The oral alkalizer (1) is administered for six months.
Interventions/Control_2
The oral alkalizer (2) is administered for six months.
Interventions/Control_3
The standard treatment is done for six months.
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
| 81 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) A patient with chronic kidney disease and age >= 20. < 81 years.
2) Signed and dated informed consent document indicating that patient has been informed of all pertinent aspects of this trial prior to enrollment.
Key exclusion criteria
1) Serious heart disease or liver disease.
2) Patients with alkaline urine.
3) Patients who are judged unfit to enroll in this trial by the investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadayoshi Ito |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Vascular Medicine.
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574
TEL
022-717-7161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiaki Abe |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Vascular Medicine.
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574
TEL
022-273-6289
Homepage URL
michiabe@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
東北大学病院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
Management information
Registered date
| 2013 | Year | 02 | Month | 17 | Day |
Last modified on
| 2013 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011775
| 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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