A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations
TRUST
Specified Drug Use-Results Survey on Long-Term Treatment for Prograf® Capsules 0.5 mg, 1 mg Lupus Nephritis
1 other identifier
observational
1,484
1 country
8
Brief Summary
To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2007
CompletedFirst Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedOctober 22, 2024
March 1, 2020
12.8 years
August 4, 2011
October 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of renal events (renal failure and progression to dialysis)
Up to 10 years
Secondary Outcomes (3)
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
Study Arms (1)
tacrolimus group
Oral
Interventions
Eligibility Criteria
patients receiving tacrolimus for the treatment of lupus nephritis
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyusyu, Japan
Unknown Facility
Shagoku, Japan
Unknown Facility
Shikoku, Japan
Unknown Facility
Tōhoku, Japan
Related Publications (2)
Takeuchi T, Wakasugi N, Hashida T, Uno S, Makino H. Long-Term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis in Japan: 10-Year Analysis of the Real-World TRUST Study. J Rheumatol. 2024 Jun 1;51(6):613-621. doi: 10.3899/jrheum.2023-0210.
PMID: 38359944DERIVEDTakeuchi T, Wakasugi N, Uno S, Makino H. Long-term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis: 5-year Interim Postmarketing Surveillance Study in Japan (TRUST). J Rheumatol. 2021 Jan 1;48(1):74-81. doi: 10.3899/jrheum.191008. Epub 2020 Apr 1.
PMID: 32238515DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 5, 2011
Study Start
April 10, 2007
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
October 22, 2024
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.