NEFECON

Name of PI and Coordinator:
Gaia Coppock, MD and Krishna Kallem, MD, MPH,
Contact:
Krishna Kallem – krishna.kallem@uphs.upenn.edu, 484-358-0315
Purpose of Study/Patient Population: Randomized, double-blind , oral budesonide vs. placebo to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

TRIDENT Study (Transformative Research In Diabetic Nephropathy)

Name of PI and Coordinator:
Gaia Coppock, MD and Shira Blady
Contact: Shira Blady, bladysh@pennmedicine.upenn.edu, 215-615-3133
Purpose of Study/Patient Population:The purpose of this study is to gather a group of patients with diabetes who undergo a kidney biopsy to create a source of information with genetic, blood, and urine samples available, by which researchers can study how diabetes affects kidney function.

Name of PI and Coordinator:
Gaia Coppock, MD, Krishna Kallem, MD, MPH, Stacey Lau
Contact:
Krishna Kallem – krishna.kallem@uphs.upenn.edu, 484-358-0315
Stacey Lau – stacey.lau@uphs.upenn.edu, 215-220-9544
Purpose of Study/Patient Population: This is a multicenter, open label, randomized study investigating two dose titration regimens of oral CXA-10 in subjects ≥18 years of age with primary FSGS.

Name of PI and Coordinator or Recruiter:
- Lawrence B. Holzman, MD
- Radhakrishna Kallem, MD, MPH
Contact:
Krishna Kallem
krishna.kallem@uphs.upenn.edu
484-358-0315
Type of Study:
Observational
Purpose of Study/Patient Population:
The Cure Glomerulopathy Network (Cure GN) is a multi-disciplinary, multi-center longitudinal observational study dedicated to advancing the understanding and treatment of Minimal Change Disease (MCD), Focal and Segmental Glomerulosclerosis (FSGS), IgA Nephropathy and Membranous Nephropathy (MN) in all age groups. It is different from NEPTUNE in that it includes prevalent patients (with a kidney biopsy within the last 5 years) and also includes patients with IgA Nephropathy. It is the largest cohort study in the history of glomerular disease research.
Inclusion:
All ages with a kidney biopsy in the last 5 years showing Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), IgA Nephropathy and Membranous Nephropathy (MN); willingness to donate blood and urine during annual study visits
Exclusion:
ESRD, Solid organ or bone marrow transplant at the time of first kidney biopsy; diagnosis of any of the following at the time of biopsy: diabetes mellitus, systemic lupus erythematosus (SLE); active malignancy, except non-melanoma skin cancer; active hepatitis B or C infection, defined as a positive viral load

Name of PI and Coordinator:
Gaia Coppock, MD, Krishna Kallem, MD, MPH, Stacey Lau
Contact:
Krishna Kallem – krishna.kallem@uphs.upenn.edu, 484-358-0315
Stacey Lau – stacey.lau@uphs.upenn.edu, 215-220-9544
Purpose of Study/Patient Population: The purpose of this study is to learn if an investigational drug called Sparsentan is safe and effective in lowering the amount of protein in the urine. In this study, Sparsentan will be compared to a drug called Irbesartan, which is approved by the U.S. Food and Drug Administration (FDA) to treat high blood pressure and kidney disease caused by diabetes. Sometimes, it is also used to treat patients with proteinuria (high amount of protein in the urine). The study is recruiting patients with Focal Segmental Glomerulosclerosis (FSGS), which is a rare disease that affects the kidneys in both adults and children.

Name of PI and Coordinator or Recruiter:
- Lawrence B. Holzman, MD
- Radhakrishna Kallem, MD, MPH
Contact:
Krishna Kallem
krishna.kallem@uphs.upenn.edu
484-358-0315
Type of Study:
Observational
Purpose of Study/Patient Population:
The Nephrotic Syndrome Study Network (NEPTUNE) is a multi-disciplinary, multi-center longitudinal observational study dedicated to advancing the understanding and treatment of Minimal Change Disease (MCD), Focal and Segmental Glomerulosclerosis (FSGS), and Membranous Nephropathy (MN) in all age groups.
Inclusion:
All ages with Suspected new diagnosis of Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), and Membranous Nephropathy (MN) BEFORE the biopsy. The subjects MUST be enrolled in the study before the biopsy and continuation in the study is subject to the biopsy results showing the target conditions. Documented urinary protein excretion ⩾500mg/24 hr or urine spot protein/creatinine ratio of ≥ 0.5.
Exclusion:
Prior solid organ transplant; Clinical, Serological or histological evidence of systemic lupus erythematosus (SLE; Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesicoureteral reflux or renal dysplasia); Known systemic disease diagnosis at time of enrollment with life expectancy less than 6 months

Name of PI and Coordinator:
Gaia Coppock, MD, Krishna Kallem, MD, MPH, Stacey Lau
Contact:
Krishna Kallem – krishna.kallem@uphs.upenn.edu, 484-358-0315
Stacey Lau – stacey.lau@uphs.upenn.edu, 215-220-9544
Purpose of Study/Patient Population: The purpose of the study is to test the safety and tolerability of an investigational drug OMS721 in people with Immunoglobulin A (IgA) Nephropathy. IgA produces abnormal amounts of a protein called IgA in the kidney that damage the filtering units of glomeruli. Glomeruli are tiny filtering units in the kidney that remove excess fluid and waste from your blood stream.