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Multicenter,Randomized,Parallel Study of Spherical Adsorptive Carbon (KREMEZIN) in Patients with Early Stage Chronic Kidney Disease of Nephropathy due to Type 2 Diabetes

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000218
Enrollment
200
Registered
2005-09-14
Start date
2005-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-stage renal failure due to type 2 diabetic nephropathy

Interventions

Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade and Kremezin Angiotensin converting enzyme inhibitor and/or Angiotensin II receptor blockade

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Hospitalization from cardiovascular causes. The changes in the level of estimated GFR, serum creatinine and proteinuria.

Countries

Japan

Contacts

Public ContactTsuyoshi Kouki

Office of the OKINAWA Study Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine

tkouki@ryudai2nai.com098-895-1146

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026