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A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients (APPLE)

This study has been terminated.
(Study terminated due to poor patient recruitment.)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier:
NCT01316133
First received: March 14, 2011
Last updated: September 6, 2016
Last verified: September 2016
  Purpose
This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.

Condition Intervention Phase
Lupus Nephritis
Drug: tacrolimus
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Remission rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Percentage of the patients who shows complete remission or partial remission


Secondary Outcome Measures:
  • Complete remission rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in urine protein to creatinine ratio [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in serum creatinine [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs [ Time Frame: for 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: February 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus group
Oral
Drug: tacrolimus
oral
Other Names:
  • Prograf
  • FK506

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
  • Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
  • Patients with refractory lupus nephritis
  • Proteinuria ≥ 0.5 g/day
  • Patients who took steroid ≥ 20 mg/day over one month prior to the study
  • Patients who failed a first-line therapy (non-responders to steroid monotherapy)

Exclusion Criteria:

  • Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
  • Patients who received tacrolimus in the past (excluding drugs for external use)
  • Patients who used other immunosuppressants within 4 weeks before initiation of the study
  • Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
  • Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
  • Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
  • Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
  • Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316133

Locations
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Incheon, Korea, Republic of
Jeonju, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT01316133     History of Changes
Other Study ID Numbers: PRGLN-10-01-KOR 
Study First Received: March 14, 2011
Last Updated: September 6, 2016
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Prograf
FK506
Proteinuria
Calcineurin inhibitor

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016