Risk Factors Underlying Increased Susceptibility and Severity of Lupus Nephritis

Study ID
STU 092010-076

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Natalie Johnson
214-645-8263
natalie.johnson@utsouthwestern.edu

Principal Investigator
Ramesh Saxena

Summary

This is a longitudinal, prospective, observational pilot feasibility study with three study groups: Lupus nephritis(Ln) (200 participants), other kidney disease (non-inflammatory kidney Disease) (Control Group a/ 100 participants) and Healthy volunteers (Control Group B/ 30 participants). The Ln group will be followed for 5 years with a Screening Visit, Baseline Visit and every 6 or 12 weeks visits with blood and urine samples based on the severity of their Ln. The non-inflammtory and healthy volunteer groups will have 1 visit ( Baseline/ Visit 1) with no other follow up visits or data collected. This is an observational study and not a treatment study.

at the Baseline Visit, the 3 groups will have the same procedures ( excluding tests specifically for lupus patients) where urine and blood samples will be collected, standard of care laboratory reports ( urine and blood) collected for their medical records, standard of care collection of spare renal biopsy tissue (excluding healthy volunteers/ required for Ln patients/ tissue will be collected for the non-inflammatory group only if they have a biospy for standard of care, but kidney biospy tissue is not required for this group). a history and physical completed, social and economic level. The specific blood and urine test are listed in the study protocol.

We hope to identify which markers are more effective and discover new diagnostic methods that can lead to early identification of lupus and lupus flares that lead to lupus nephritis and later end stage renal disease.

Participant Eligibility

General Inclusion criteria:
1. Age: 18 years or above
2. Gender: Males and females
3. Race: Any. No race or ethnic group will not be excluded

Lupus Nephritis Group:
1. Medical diagnosis of lupus and lupus Nephritis
2. SLE: Patient must have been scheduled for kidney biopsy as a part of standard
Care (Excluding Healthy Volunteers and non-inflammatory renal diseases)

Other Renal Disease Group:
1. Must have a medical diagnosis of a non-inflammatory renal disease like diabetic nephropathy (DN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS) and membranous nephropathy (MN) as well as inflammatory renal diseases such as IgA nephropathy and ANCA-associated glomerulonephritis

Healthy Volunteer Group:
1. Healthy good general health without any form of kidney disease


TREM-1 Substudy:


General Inclusion criteria:
1. Age: 18 years or above(TREM-1 substudy age cutoff is 65 years old)
2. Gender: Males and females
3. Race: Any. No race or ethnic group will not be excluded

Lupus Nephritis (LN) Group:
1. Medical diagnosis of lupus and lupus Nephritis
2. SLE: Patient must have been scheduled for kidney biopsy as a part of standard
Care (Excluding Healthy Volunteers and non-inflammatory renal diseases)

Other Renal Disease (RD) Group:
1. Must have a medical diagnosis of a non-inflammatory renal disease like diabetic nephropathy (DN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS) and membranous nephropathy (MN) as well as inflammatory renal diseases such as IgA nephropathy and ANCA-associated glomerulonephritis