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

Astellas

Status and phase

Completed

Phase 2

Conditions

IgA Nephropathy

Treatments

Drug: Placebo

Drug: Tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01224028

PRGNS-10-01-KOR

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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