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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010059
Receipt No. 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

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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
Email

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
Email michiabe@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011775

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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