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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000218
Receipt No. R000000057
Scientific Title Multicenter,Randomized,Parallel Study of Spherical Adsorptive Carbon (KREMEZIN) in Patients with Early Stage Chronic Kidney Disease of Nephropathy due to Type 2 Diabetes
Date of disclosure of the study information 2005/09/14
Last modified on 2009/01/20

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Basic information
Public title Multicenter,Randomized,Parallel Study of Spherical Adsorptive Carbon (KREMEZIN) in Patients with Early Stage Chronic Kidney Disease of Nephropathy due to Type 2 Diabetes
Acronym Okinawa Study for Kremezin in Patients with DiAbetic Nephropathy (OKINAWA)
Scientific Title Multicenter,Randomized,Parallel Study of Spherical Adsorptive Carbon (KREMEZIN) in Patients with Early Stage Chronic Kidney Disease of Nephropathy due to Type 2 Diabetes
Scientific Title:Acronym Okinawa Study for Kremezin in Patients with DiAbetic Nephropathy (OKINAWA)
Region
Japan

Condition
Condition Early-stage renal failure due to type 2 diabetic nephropathy
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of Kremezin on progression to early-stage diabetic nephropathy in patients who develop renal failure in spite of ACEI and/or ARB administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Doubling of the serum creatinine concentration. More than 15 mL/min of the decrement of estimated GFR. The need for long-term dialysis. Renal transplantation. Death.
Key secondary outcomes Hospitalization from cardiovascular causes. The changes in the level of estimated GFR, serum creatinine and proteinuria.

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 considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade and Kremezin
Interventions/Control_2 Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) outpatient 2) age over 20 3) estimated GFR (eGFR), calculated by MDRD equation, is between 30 mL/min and 60 mL/min. the ratio of latest eGFR (eGFR2) and eGFR over 3 months before the day of eGFR2 measurement (eGFR1) is under 0.95 (eGFR2/eGFR1 <= 0.95) 4) over excretion of proteinuria (+- <= using paper test, or 30 mg/dL <= the concentration of proteinuria) 5) therapy with Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade continuously 6) periodical diet therapy 7) diabetic retinopathy
Key exclusion criteria 1) stenosis of alimentary tract 2) severe constipation 3) event of myocardial infarction, cerebral infarction and cerebral hemorrhage within three months 4) malignant disease within 5 years 5) severe nephrosis (serum albumin < 2 g/dL) 6) pregnancy, patient's hope to be pregnant or breast-feeding 7) very poor control of diabetes mellitus (10.0 % <= HbA1c for six months continuously) 8) the case, regarded as unsuitable by doctors
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Komiya
Organization University of the Ryukyus School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 207, Uehara, Nishihara, Okinawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Kouki
Organization Office of the OKINAWA Study
Division name Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine
Zip code
Address 207, Uehara, Nishihara, Okinawa
TEL 098-895-1146
Homepage URL
Email tkouki@ryudai2nai.com

Sponsor
Institute Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2005 Year 09 Month 14 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 No longer recruiting
Date of protocol fixation
2004 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2011 Year 12 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
2005 Year 09 Month 13 Day
Last modified on
2009 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000057

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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