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Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

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ClinicalTrials.gov Identifier: NCT01470183
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : February 7, 2014
Sponsor:
Collaborator:
Centocor Research & Development, Inc.
Information provided by (Responsible Party):
Gerald B. Appel, Columbia University

November 7, 2011
November 11, 2011
February 7, 2014
October 2011
February 2013   (Final data collection date for primary outcome measure)
  • Change in mRNA [ Time Frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 ]
    Whole blood samples will be collected from all subjects for the analysis of mRNA expression of genes relevant to lupus nephritis (IFNa signature, TNFa/TNFa receptor families, defensins, TH1, TH17 related pathway genes.
  • Change in Proteinuria [ Time Frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 ]
    Urine (12-hour collections) will be obtained from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
  • Change in Creatinine [ Time Frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 ]
    Serum will be collected from all subjects in the study for the analysis of proteins relevant to lupus nephritis.
Same as current
Complete list of historical versions of study NCT01470183 on ClinicalTrials.gov Archive Site
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Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

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
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Approximately 50 adult patients, 25 with lupus nephritis 25 control patients who have greater than 1 gram per day proteinuria and non-SLE diagnoses, and who qualify for this study based upon the stated inclusion/exclusion criteria will be recruited from the Glomerular Center at Columbia University Medical Center.
Lupus Nephritis
Not Provided
  • 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
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
50
February 2013
February 2013   (Final data collection date for primary outcome measure)

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.
  • 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 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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01470183
AAAI1090
No
Not Provided
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Gerald B. Appel, Columbia University
Columbia University
Centocor Research & Development, Inc.
Principal Investigator: Gerald Appel, MD Columbia University
Columbia University
February 2014