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

NCT ID: NCT01410747

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1484 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-10

Study Completion Date

2020-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lupus Nephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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tacrolimus group

Oral

Tacrolimus

Intervention Type DRUG

oral

Interventions

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Tacrolimus

oral

Intervention Type DRUG

Other Intervention Names

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FK506

Eligibility Criteria

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Inclusion Criteria

patients receiving tacrolimus for the treatment of lupus nephritis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kantou, , Japan

Site Status

Kyusyu, , Japan

Site Status

Shagoku, , Japan

Site Status

Shikoku, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 38359944 (View on PubMed)

Takeuchi 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.

Reference Type DERIVED
PMID: 32238515 (View on PubMed)

Other Identifiers

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PRGN01

Identifier Type: -

Identifier Source: org_study_id

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