Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

This study has been completed.
Sponsor:
Collaborator:
Centocor Research & Development, Inc.
Information provided by (Responsible Party):
Gerald B. Appel, Columbia University
ClinicalTrials.gov Identifier:
NCT01470183
First received: November 7, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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

Condition
Lupus Nephritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in mRNA [ Time Frame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Serum will be collected from all subjects in the study for the analysis of proteins relevant to lupus nephritis.


Enrollment: 46
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470183

Locations
United States, New York
Columbia University Medical Center, Division of Nephrology, Glomerular Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Centocor Research & Development, Inc.
Investigators
Principal Investigator: Gerald Appel, MD Columbia University
  More Information

No publications provided

Responsible Party: Gerald B. Appel, Professor of Clinical Medicine, Nephrology, Columbia University
ClinicalTrials.gov Identifier: NCT01470183     History of Changes
Other Study ID Numbers: AAAI1090
Study First Received: November 7, 2011
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Lupus Nephritis

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014