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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Early-stage renal failure due to type 2 diabetic nephropathy | |||
Classification by specialty |
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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 |
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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 | |
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Eligibility | ||||
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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 |
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Organization | University of the Ryukyus School of Medicine | ||||||
Division name | Department of Endocrinology and Metabolism | ||||||
Zip code | |||||||
Address | 207, Uehara, Nishihara, Okinawa | ||||||
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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 | |||||||
tkouki@ryudai2nai.com |
Sponsor | |
Institute | Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine |
Institute | |
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Funding Source | |
Organization | Japan Society for the Promotion of Science |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Baseline Characteristics | |
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Recruitment status | No longer recruiting | ||||||
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Last modified on |
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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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