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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01410747
First received: August 4, 2011
Last updated: May 8, 2017
Last verified: May 2017
  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 ]

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 ]
  • 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 ]

Enrollment: 1484
Actual Study Start Date: January 1, 2007
Estimated Study Completion Date: January 31, 2020
Estimated Primary Completion Date: January 31, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
tacrolimus group
Oral
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410747

Locations
Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shagoku, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01410747     History of Changes
Other Study ID Numbers: PRGN01
Study First Received: August 4, 2011
Last Updated: May 8, 2017

Keywords provided by Astellas Pharma Inc:
long-term treatment
tacrolimus
renal failure

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2017