Status:
COMPLETED
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Centocor Research & Development, Inc.
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-80 years
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 biomark...
Eligibility Criteria
Inclusion
- 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.
- Clarification of inclusion criteria for controls: 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01470183
Start Date
October 1 2011
End Date
February 1 2013
Last Update
February 7 2014
Active Locations (1)
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1
Columbia University Medical Center, Division of Nephrology, Glomerular Center
New York, New York, United States, 10032