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

Astellas Pharma Inc40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

IgA Nephropathy

Interventions

TacrolimusDRUG

oral

PlaceboDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)

Time frame: Week 0, week 12 and week 16

Secondary Outcomes

Proportion of subjects achieving more than 30% reduction of UACR level from baseline

Time frame: Week 0 and week 16

Proportion of subjects achieving more than 50% reduction of UACR level from baseline

Time frame: Week 0 and week 16

Proportion of subjects achieving more than 0.2 reduction of UACR level

Time frame: Week 0 and week 16

Composite event rate achieving less than 0.2 or 50% reduction of UACR level

Time frame: Week 0 and week 16

Changes of UACR measured between before the study and each visit

Time frame: Week 0, week 4, week 8, week 12 and week 16

Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests

Time frame: Through week 16

Data from ClinicalTrials.gov

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