Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00479622
• Other study ID #: 3206K3-103
• Status: Terminated
• Phase: Phase 1
• First received: May 25, 2007
• Last updated: May 7, 2008
• Start date: August 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.

• Diagnosis of systemic lupus erythematosus more than 6 months before study day 1.

• History of positive antinuclear antibody titer of >1:160 or equivalent.

• Biopsy-proven class V lupus nephritis within the last 2 years.

• Have been on a stable dose of oral corticosteroids (<20 mg/day prednisone or equivalent) for 2 months before study day 1.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Kidney Diseases
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• TRU-015
Arm 1 = 800 mg Arm 2 = 2000 mg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	Emergent Product Development Seattle LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus.		6 months	No
Secondary	To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus.		1 year	Yes