Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

NCT01470183 | Completed

• 1 other identifier: AAAI1090
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Lupus Nephritis

Outcome Measures

Primary Outcomes (3)

• Change in mRNA

  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.

  Week 0, and Months 1, 2, 4, 6, 8, 10 and 12

• Change in Proteinuria

  Urine (12-hour collections) will be obtained from all subjects in the study for the analysis of proteins relevant to lupus nephritis.

  Week 0, and Months 1, 2, 4, 6, 8, 10 and 12

• Change in Creatinine

  Serum will be collected from all subjects in the study for the analysis of proteins relevant to lupus nephritis.

  Week 0, and Months 1, 2, 4, 6, 8, 10 and 12

Study Arms (2)

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Centocor Research & Development, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center, Division of Nephrology, Glomerular Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gerald Appel, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine, Nephrology

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 11, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

US (1)