Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

NCT ID: NCT01470183

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-02-28

Brief Summary

This is an exploratory study. No formal hypothesis will be tested.

The objectives of this study are to follow Lupus Nephritis patients over a period of 12 months to:

• Establish the baseline biomarker characteristics of patients
• Determine the variability of biomarker measures over time
• Correlate biomarkers with disease phenotype

Conditions

Lupus Nephritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Lupus Nephritis Patients

1. Male or female subjects age 18 and older

2. Must have confirmed diagnosis of Class III or Class IV lupus nephritis by biopsy

3. Must have stable disease on medication at time of enrollment

No interventions assigned to this group

Control Patients

Any patient with an idiopathic glomerular disease who does not have lupus nephritis. This includes patients with minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis, and IgA nephropathy.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults between 18 and 80 years of age, inclusive
• Diagnosis of SLE by ACR criteria and biopsy-proven ISN/RPS Class III or IV lupus glomerulonephritis within 2 years
• Persistently active nephritis defined as proteinuria greater than or equal to 1.0 g/day for 3 months or more, AND at least 1 of the following:

• Hematuria (greater than or equal to 5 RBC/hpf) on 2 or more urinalyses done greater than or equal to 2 weeks apart
• anti-dsDNA positive or anti-Smith positive, or
• low C3 or C4 complement level. (d) Stable immunosuppression consisting of mycophenolate mofetil (MMF) 13 g/day with/without corticosteroids up to prednisone equivalent of 15 mg/day, or azathioprine 13 mg/kg/day with/without corticosteroids up to prednisone equivalent of 20 mg/day.
• Stable dose of ACE inhibitor/ARB for 4 weeks prior to study enrollment, unless previously intolerant to or having a contraindication to ACE inhibitors and ARBs
• If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 15 mg/day of prednisone for at least 4 weeks prior to study enrollment. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 4 weeks prior study enrollment.

Exclusion Criteria

• B-cell depletion therapy in past 1 yr, or evidence of persistent B cell depletion at the time of screening.
• Received an investigational drug (including vaccines) or used an investigational medical device within 3 months of study enrollment or within 5 half-lives of agent, whichever is longer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor Research & Development, Inc.

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Gerald B. Appel

Professor of Clinical Medicine, Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Appel, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center, Division of Nephrology, Glomerular Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAI1090

Identifier Type: -

Identifier Source: org_study_id