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Completed

NCT Number: NCT01224028

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

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.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: Prograf, FK506

Placebo

Drug

oral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2010
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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