Overview

This trial is active, not recruiting.

Condition lupus nephritis
Treatment tacrolimus
Sponsor Astellas Pharma Inc
Start date January 2007
End date January 2020
Trial size 1484 participants
Trial identifier NCT01410747, PRGN01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
tacrolimus FK506
oral

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

patients receiving tacrolimus for the treatment of lupus nephritis

Additional Information

Official title Post Marketing Surveillance For Long Term Treatment With Tacrolimus in Steroid Resistant Lupus Nephritis
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.