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

This study has been completed.
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: October 18, 2010
Last updated: October 6, 2011
Last verified: October 2011

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.

Condition Intervention Phase
IgA Nephropathy
Drug: Tacrolimus
Drug: Placebo
Phase 2

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
Official 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving more than 30% reduction of UACR level from baseline [ Time Frame: Week 0 and week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving more than 50% reduction of UACR level from baseline [ Time Frame: Week 0 and week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving more than 0.2 reduction of UACR level [ Time Frame: Week 0 and week 16 ] [ Designated as safety issue: No ]
  • Composite event rate achieving less than 0.2 or 50% reduction of UACR level [ Time Frame: Week 0 and week 16 ] [ Designated as safety issue: No ]
  • Changes of UACR measured between before the study and each visit [ Time Frame: Week 0, week 4, week 8, week 12 and week 16 ] [ Designated as safety issue: No ]
  • Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests [ Time Frame: Through week 16 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus group Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224028

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01224028     History of Changes
Other Study ID Numbers: PRGNS-10-01-KOR
Study First Received: October 18, 2010
Last Updated: October 6, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Calcinurin inhibitor

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014