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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01224028
• Date of registration: 18/10/2010
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Inc
• Public title: A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
• Scientific title: Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy
• Date of first enrolment: November 2010
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01224028
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Use Central Contact
• Affiliation: Astellas Pharma Inc

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: Placebo

Drug: Tacrolimus

Primary Outcome(s)

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 Outcome(s)

Composite event rate achieving less than 0.2 or 50% reduction of UACR level [Time Frame: Week 0 and week 16]

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

Proportion of subjects achieving more than 0.2 reduction of UACR level [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]

Secondary ID(s)

PRGNS-10-01-KOR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Astellas Pharma Korea, Inc.