A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations

Astellas Pharma Inc1,484 enrolled

Overview

To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.

The objectives of the survey are to evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use situations, and to identify factors that might affect the safety and efficacy of tacrolimus. In addition, long-term renal outcome will be evaluated.

Study Type

OBSERVATIONAL

Enrollment

1,484

Conditions

Lupus Nephritis

Interventions

TacrolimusDRUG

oral

Eligibility

Sex: ALL

Medical Language ↔ Plain English

patients receiving tacrolimus for the treatment of lupus nephritis

Locations (8)

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Unnamed facility

Kyusyu, Japan

Outcomes

Primary Outcomes

Incidence of renal events (renal failure and progression to dialysis)

Time frame: Up to 10 years

Secondary Outcomes

24-hour urinary protein

Time frame: Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year

Urinary red blood cell (RBC) count

Time frame: Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year

Serum creatinine

Time frame: Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year

Data from ClinicalTrials.gov

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