Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01224028
Start Date
November 1 2010
End Date
June 1 2011
Last Update
August 21 2014
Active Locations (1)
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1
Seoul, South Korea