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

August 20, 2014 updated by: Astellas Pharma Inc

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral
Experimental: Tacrolimus group
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 0, week 12 and week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving more than 30% reduction of UACR level from baseline
Time Frame: Week 0 and week 16
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
Week 0 and week 16
Proportion of subjects achieving more than 0.2 reduction of UACR level
Time Frame: Week 0 and week 16
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
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
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
Through week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Korea, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimate)

October 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRGNS-10-01-KOR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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