Clinical trial NCT01470183: Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
Official title: Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centocor Research & Development, Inc.
First posted: 2011-11-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


Eligibility 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.

Primary outcomes:
measure: Change in mRNA
timeFrame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
measure: Change in Proteinuria
timeFrame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
measure: Change in Creatinine
timeFrame: Week 0, and Months 1, 2, 4, 6, 8, 10 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center, Division of Nephrology, Glomerular Center
state: New York
Study officials:
affiliation: Columbia University
name: Gerald Appel, MD
role: PRINCIPAL_INVESTIGATOR
References: