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

Phase 2

Completed

• Conditions: IgA Nephropathy
• Interventions: Drug: Placebo; Drug: Tacrolimus

• Registration Number: NCT01224028
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Study Start: 2010-11
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-20
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tacrolimus group	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)	Week 0, week 12 and week 16

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving more than 30% reduction of UACR level from baseline	Week 0 and week 16
Composite event rate achieving less than 0.2 or 50% reduction of UACR level	Week 0 and week 16
Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests	Through week 16
Proportion of subjects achieving more than 50% reduction of UACR level from baseline	Week 0 and week 16
Proportion of subjects achieving more than 0.2 reduction of UACR level	Week 0 and week 16
Changes of UACR measured between before the study and each visit	Week 0, week 4, week 8, week 12 and week 16