Unique ID issued by UMIN | C000000218 |
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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 |
Multicenter,Randomized,Parallel Study of Spherical Adsorptive Carbon (KREMEZIN) in Patients with Early Stage Chronic Kidney Disease of Nephropathy due to Type 2 Diabetes
Okinawa Study for Kremezin in Patients with DiAbetic Nephropathy (OKINAWA)
Multicenter,Randomized,Parallel Study of Spherical Adsorptive Carbon (KREMEZIN) in Patients with Early Stage Chronic Kidney Disease of Nephropathy due to Type 2 Diabetes
Okinawa Study for Kremezin in Patients with DiAbetic Nephropathy (OKINAWA)
Japan |
Early-stage renal failure due to type 2 diabetic nephropathy
Medicine in general | Endocrinology and Metabolism | Nephrology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase IV
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.
Hospitalization from cardiovascular causes. The changes in the level of estimated GFR, serum creatinine and proteinuria.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as a block.
NO
Central registration
2
Treatment
Medicine |
Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade and Kremezin
Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade
20 | years-old | <= |
Not applicable |
Male and Female
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
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
200
1st name | |
Middle name | |
Last name | Ichiro Komiya |
University of the Ryukyus School of Medicine
Department of Endocrinology and Metabolism
207, Uehara, Nishihara, Okinawa
1st name | |
Middle name | |
Last name | Tsuyoshi Kouki |
Office of the OKINAWA Study
Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine
207, Uehara, Nishihara, Okinawa
098-895-1146
tkouki@ryudai2nai.com
Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine
Japan Society for the Promotion of Science
NO
2005 | Year | 09 | Month | 14 | Day |
Unpublished
No longer recruiting
2004 | Year | 12 | Month | 27 | Day |
2005 | Year | 09 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 13 | Day |
2009 | Year | 01 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000057
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