Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

Lupus Nephritis Clinical Trial

Official title:

Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470183
• Other study ID #: AAAI1090
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: February 5, 2014
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Locations

Country	Name	City	State
United States	Columbia University Medical Center, Division of Nephrology, Glomerular Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centocor Research & Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No