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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01224028
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : August 21, 2014
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Tacrolimus Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Tacrolimus group Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. 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 Measures :
  1. Proportion of subjects achieving more than 30% reduction of UACR level from baseline [ Time Frame: Week 0 and week 16 ]
  2. Proportion of subjects achieving more than 50% reduction of UACR level from baseline [ Time Frame: Week 0 and week 16 ]
  3. Proportion of subjects achieving more than 0.2 reduction of UACR level [ Time Frame: Week 0 and week 16 ]
  4. Composite event rate achieving less than 0.2 or 50% reduction of UACR level [ Time Frame: Week 0 and week 16 ]
  5. Changes of UACR measured between before the study and each visit [ Time Frame: Week 0, week 4, week 8, week 12 and week 16 ]
  6. Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests [ Time Frame: Through week 16 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT01224028     History of Changes
Other Study ID Numbers: PRGNS-10-01-KOR
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Calcinurin inhibitor

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action