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

Lupus Nephritis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01316133
• Other study ID #: PRGLN-10-01-KOR
• Status: Terminated
• Phase: Phase 4
• Start date: April 19, 2011
• Est. completion date: April 8, 2016

Study information

• Verified date: November 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: April 8, 2016
• Est. primary completion date: April 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• tacrolimus
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate	Percentage of the patients who shows complete remission or partial remission	24 weeks
Secondary	Complete remission rate		24 weeks
Secondary	Change from baseline in urine protein to creatinine ratio		Baseline, 4 weeks, 12 weeks and 24 weeks
Secondary	Change from baseline in serum creatinine		Baseline, 4 weeks, 12 weeks and 24 weeks
Secondary	Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs		for 24 weeks

External Links

•   Link to results on the Astellas Clinical Study Results website