Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00429377
• Collaborator: (none)
• Enrollment: 64
• Locations: 7
• Patients Per Site: 9.1

Study Details

Study Description

Brief Summary

This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: tacrolimus	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
• Study Start Date: Jun 1, 2003

Outcome Measures

Primary Outcome Measures

1. Change of Lupus Nephritis - Disease Activity Index total score []

Secondary Outcome Measures

1. proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Steroid refractory lupus nephritis

• more than 10mg of steroid failed to control disease activity

• patients who failed to reduce the amount of steroid

• patients who couldn't increase the amount of steroid due to side effects

Exclusion Criteria:

• Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration

• Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration

• CNS( Central Nerve System) Lupus patients

• hepatic failure patients

• Serum creatinine ≧1.5mg/dL

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chubu region		Japan
2		Hokkaido region		Japan
3		Hokuriku region		Japan
4		Kansai region		Japan
5		Kanto region		Japan
6		Shikoku region		Japan
7		Tohoku region		Japan

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Use Central Contact, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00429377
• Other Study ID Numbers: 506-LN02
• First Posted: Jan 31, 2007
• Last Update Posted: Jan 31, 2007
• Last Verified: Jan 1, 2007

• Keywords provided by , ,: tacrolimus; FK506; lupus nephritis
• Additional relevant MeSH terms: Nephritis; Lupus Nephritis; Tacrolimus

Study Results

No Results Posted as of Jan 31, 2007