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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: March 14, 2011
Last updated: October 27, 2015
Last verified: October 2015
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 ]

Estimated Enrollment: 56
Study Start Date: February 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus group Drug: tacrolimus
Other Names:
  • Prograf
  • FK506


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Contact: Clinical Development Administration Dept. Astellas.registration@astellas.com

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 Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01316133     History of Changes
Other Study ID Numbers: PRGLN-10-01-KOR 
Study First Received: March 14, 2011
Last Updated: October 27, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Calcineurin inhibitor

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

ClinicalTrials.gov processed this record on May 24, 2016