UMIN-CTR Clinical Trial

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
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IRB Contact (For public release)
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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
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Number of participants that the trial has enrolled
Results
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Results Delayed
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Baseline Characteristics
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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
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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
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Research case data
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