A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Calcineurin Inhibitors; Tacrolimus

Criteria

Inclusion Criteria:

• Patients with IgA nephropathy confirmed by renal biopsy

• Serum creatinine measurement ≤1.5mg/ml or MDRD estimated GFR ≥ 45ml/min/1.73m2 (MDRD:

Modification of Diet in Renal Disorder)

• UACR level between 0.3 and 3.0

• Blood pressure measurements < 130/80mmHg

Exclusion Criteria:

• Use of immunosuppressants for more than two weeks within last one month

• Concomitant use of ACE inhibitor, ARB, steroids or immunosuppressant, NDHP-CCB, diuretics, omega-3 fatty acids and its analogue & additional dietary to treat igA nephropathy (ACE: Angiotensin Converting Enzyme, ARB: Angiotensin Receptor Blocker, NDHP-CCB: Non-dihydropyridine-type Calcium Channel Blocker

• Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study

• Hypersensitivity to the investigational drug or macrolide agents

• Use of potassium-sparing diuretics

• Persistence of liver function abnormality more than 1 month or presence of acute active hepatitis

• Other investigational drug within last 30 days