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: July 8, 2013
Last verified: July 2013
  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 ]

Enrollment: 1484
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
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

No publications provided

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: July 8, 2013
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 July 20, 2014