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

Specified Drug Use-Results Survey on Long-Term Treatment for Prograf® Capsules 0.5 mg, 1 mg Lupus Nephritis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01410747

Acronym

TRUST

Enrollment

1484

Registered

2011-08-05

Start date

2007-04-10

Completion date

2020-01-31

Last updated

2024-10-22

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

Conditions

Lupus Nephritis

Keywords

long-term treatment, tacrolimus, renal failure

Brief summary

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

Detailed description

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.

Interventions

DRUGTacrolimus

oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

patients receiving tacrolimus for the treatment of lupus nephritis

Design outcomes

Primary

Measure	Time frame
Incidence of renal events (renal failure and progression to dialysis)	Up to 10 years

Secondary

Measure	Time frame
24-hour urinary protein	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	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	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026