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

Primary Purpose

Lupus Nephritis

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tacrolimus
Sponsored by
Astellas Pharma Korea, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Tacrolimus, Prograf, FK506, Proteinuria, Calcineurin inhibitor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tacrolimus group

Arm Description

Oral

Outcomes

Primary Outcome Measures

Remission rate
Percentage of the patients who shows complete remission or partial remission

Secondary Outcome Measures

Complete remission rate
Change from baseline in urine protein to creatinine ratio
Change from baseline in serum creatinine
Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs

Full Information

First Posted
March 14, 2011
Last Updated
November 26, 2018
Sponsor
Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01316133
Brief Title
A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients
Acronym
APPLE
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to poor patient recruitment.
Study Start Date
April 19, 2011 (Actual)
Primary Completion Date
April 8, 2016 (Actual)
Study Completion Date
April 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Korea, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Tacrolimus, Prograf, FK506, Proteinuria, Calcineurin inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus group
Arm Type
Experimental
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Prograf, FK506
Intervention Description
oral
Primary Outcome Measure Information:
Title
Remission rate
Description
Percentage of the patients who shows complete remission or partial remission
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Complete remission rate
Time Frame
24 weeks
Title
Change from baseline in urine protein to creatinine ratio
Time Frame
Baseline, 4 weeks, 12 weeks and 24 weeks
Title
Change from baseline in serum creatinine
Time Frame
Baseline, 4 weeks, 12 weeks and 24 weeks
Title
Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs
Time Frame
for 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Jeonju
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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 www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=209
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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