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

UMIN ID: C000000218

Registered date:14/09/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Early-stage renal failure due to type 2 diabetic nephropathy
• Date of first enrollment: 2005/09/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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 Outcome: Hospitalization from cardiovascular causes. The changes in the level of estimated GFR, serum creatinine and proteinuria.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Endocrinology and Metabolism, University of the Ryukyus School of Medicine
• Source(s) of Monetary Support: Japan Society for the Promotion of Science