A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations (TRUST)
This study is currently recruiting participants.
Verified August 2011 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01410747
First received: August 4, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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Purpose
To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.
| Condition | Intervention |
|---|---|
|
Lupus Nephritis |
Drug: Tacrolimus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Post Marketing Surveillance For Long Term Treatment With Tacrolimus in Steroid Resistant Lupus Nephritis |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Incidence of renal events (renal failure and progression to dialysis) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| tacrolimus group |
Drug: Tacrolimus
oral
Other Name: FK506
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients receiving tacrolimus for the treatment of lupus nephritis
Criteria
patients receiving tacrolimus for the treatment of lupus nephritis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410747
Contacts
| Contact: Clinical Development Administration Dept. | clinicaltrials_info@jp.astellas.com |
Locations
| Japan | |
| Recruiting | |
| Chubu, Japan | |
| Recruiting | |
| Hokkaido, Japan | |
| Recruiting | |
| Kansai, Japan | |
| Recruiting | |
| Kantou, Japan | |
| Recruiting | |
| Kyusyu, Japan | |
| Recruiting | |
| Shagoku, Japan | |
| Recruiting | |
| Shikoku, Japan | |
| Recruiting | |
| Touhoku, Japan | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Use Central Contact | Astellas Pharma Inc |
More Information
No publications provided
| Responsible Party: | Director, Astellas Pharma, Inc |
| ClinicalTrials.gov Identifier: | NCT01410747 History of Changes |
| Other Study ID Numbers: | PRGN01 |
| Study First Received: | August 4, 2011 |
| Last Updated: | August 4, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Astellas Pharma Inc:
|
tacrolimus renal failure long-term treatment |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013