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

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: NCT01316133
Recruitment Status : Terminated (Study terminated due to poor patient recruitment.)
First Posted : March 16, 2011
Last Update Posted : November 27, 2018
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Lupus Nephritis Drug: tacrolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : April 19, 2011
Actual Primary Completion Date : April 8, 2016
Actual Study Completion Date : April 8, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

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

Primary Outcome Measures :
  1. Remission rate [ Time Frame: 24 weeks ]
    Percentage of the patients who shows complete remission or partial remission

Secondary Outcome Measures :
  1. Complete remission rate [ Time Frame: 24 weeks ]
  2. Change from baseline in urine protein to creatinine ratio [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ]
  3. Change from baseline in serum creatinine [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ]
  4. Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs [ Time Frame: for 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01316133

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.
Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Korea, Inc. Identifier: NCT01316133     History of Changes
Other Study ID Numbers: PRGLN-10-01-KOR
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on under "Sponsor Specific Details for Astellas."

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
Calcineurin inhibitor

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