UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000218
Receipt number 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 18:51:18

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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