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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: tacrolimus

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus group; Oral	Drug: tacrolimus; oral; Other Names: Prograf; FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission rate	Percentage of the patients who shows complete remission or partial remission	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete remission rate	24 weeks
Change from baseline in urine protein to creatinine ratio	Baseline, 4 weeks, 12 weeks and 24 weeks
Change from baseline in serum creatinine	Baseline, 4 weeks, 12 weeks and 24 weeks
Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs	for 24 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Korea, Inc.
• Investigators: Study Chair: Use Central Contact, Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2011
• Primary Completion (Actual): April 8, 2016
• Study Completion (Actual): April 8, 2016

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimated): March 16, 2011

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Tacrolimus; Prograf; Proteinuria; FK506; Calcineurin inhibitor
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: PRGLN-10-01-KOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.