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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01316133

Acronym

APPLE

Enrollment

Registered

2011-03-16

Start date

2011-04-19

Completion date

2016-04-08

Last updated

2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Keywords

Tacrolimus, Prograf, FK506, Proteinuria, Calcineurin inhibitor

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.

Interventions

DRUGtacrolimus

oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026