Therapeutic effect of an immunosupp-ressive agent, mizoribine in patients with the progression of renal failure in diabetic nephropathy

UMIN ID: UMIN000001824

Registered date:31/03/2009

Basic Information

• Health condition(s) or Problem(s) studied: Diabetic nephropathy
• Date of first enrollment: 2008/07/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Conventional therapy for diabetic nephropathy
Conventional therapy for diabetic nephropathy + MZR

Outcome(s)

• Primary Outcome: The mean gradient of the reciprocal serum creatinine levels between MZR treated and non-treated.
• Secondary Outcome: The frequency of lethal event and non-lethal event.Lethal event: myocardial infarction(angina pectoris)Non-lethal event: state of renal failure increasing to 5.00mg/dl or more of s-Cr. level.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: Patients who is received cortico- steroid or immunosuppressant.Patients whose blood pressure is over 160/100mmHg or whose HbA1c is over 10.0%.Patients with a hypersensitivity to MZR.Patients whose WBC are under 3000/mm3.Pregnant or nursing women.

Related Information

• Primary Sponsor: Okayama University
• Source(s) of Monetary Support: None