Clinical Trials Ongoing In Our Division


Study Title
Status
Conditions

1.Nephrotic Syndrome Study Network (NEPTUNE)
Active/Recruiting
Minimal Change Disease (MCD)
Focal Segmental Glomerulosclerosis (FSGS)
Membranous Nephropathy (MN)
IgA Nephropathy (IgAN)

2. Cure Glomerulonephropathy (CureGN)
Active/Recruiting
Minimal Change Disease (MCD)
Focal Segmental Glomerulosclerosis (FSGS)
Membranous Nephropathy (MN)
IgA Nephropathy (IgAN)

3. Characterization of Human Podocyte Gene Signature in Health and Disease
Active/Recruiting
Patients scheduled for partial or radical nephrectomy within the Department of Urology at the University of Miami Hospital will be considered as potential candidates for the study.

4. Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) (ALE06)
Active/Recruiting
Systemic Lupus Erythematosus (SLE)

5. Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan)
in Focal Segmental Glomerulosclerosis (DUET) Active/Enrollment Closed
Focal Segmental Glomerulosclerosis (FSGS)

6. BLISS (HGS1006-C1121)
Active/Enrollment Closed
Lupus Nephritis

7. Study of Sparsentan in FSGS (DUPLEX)
Not yet recruiting
Focal Segmental Glomerulosclerosis (FSGS)

8. Transformative Research in Diabetic Nephropathy (TRIDENT)
Not yet recruiting
Diabetic Nephropathies
Diabetic Glomerulosclerosis

9. FIRSTx – A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)
Not yet recruiting
Focal Segmental Glomerulosclerosis (FSGS)

10. Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis
Not yet recruiting
Focal Segmental Glomerulosclerosis (FSGS)

11. Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit
Disease Treated With OMS721
Not yet recruiting
IgA Nephropathy (IgAN)
Lupus Nephritis
Membranous Nephropathy (MN)
C3G

Active Grants and Contracts

1R01DK090316-01A1 (NIH/NIDDK) 09/2011 – 07/2016
Novel Targets of Rituximab in FSGS
Principle Investigator: A. Fornoni, MD PhD

1R01DK104753 (NIH/NIDDK) 03/2015 – 02/2019
Cellular Cholesterol and Podocyte Function in Diabetic Kidney Disease
Principle Investigator: A. Fornoni, MD PhD

U54-DK0839120 (NIH/NIDDK) 09/2009 – 06/2019
NEPTUNE: The Nephrotic Syndrome Rare Disease Clinical Research Network
Local Principle Investigator: A. Fornoni, MD PhD

UM1-DK100846 Progress (NIH/NIDDK) 06/2013 – 05/2018
The Primary Outcome of Glomerulonephritis Study.
Local Principle Investigator: A. Fornoni, MD PhD

Hoffman La Roche Inc. 07/2014 – 06/2017
Targeting Cholesterol Efflux from Podocytes in Rare Kidney Diseases
Principle Investigator: A. Fornoni, MD PhD

Hoffman-La Roche Inc. 07/2014 – 06/2017
Targeting a Master Regulator in Alpport Syndrome: Discoidin Domain Receptor 1 (DDR-1)
Principle Investigator: A. Fornoni, MD PhD

Completed Grants and Contracts

Boehringer Ingelheim 12/2015 – 12/2019
Characterization of Human Podocyte Gene Signature in Health and Disease
Principle Investigator: A. Fornoni, MD PhD

Clinical Trial and Consulting Services 03/2015 – 03/2019
DUET: Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin receptor Blocker , In Patients with Focal Segmental Glomerulosclerosis (FSGS): A Randomized, Double-Blind, Active-Control, Dose-Escalation Study.
Local Principle Investigator: A. Fornoni, MD PhD

UM CFAR Pilot Award 11/2015 – 11/2016
Role of TNF alpha and APOL1 in HIVAN
Principle Investigator: S. Merscher, PhD

UM SAC Award 10/2015 – 03/2016
Generation and characterization of an inducible podocyte-specific SMPDL3b transgenic mouse
Principle Investigator: S. Merscher, PhD

American Heart Association PreDoctoral Award 07/2014 – 06/2016
TNF Alpha Causes Cholesterol Accumulation and Apoptosis in Diabetic Kidney Disease
Principle Investigator: C. Pedigo, Mentor: S. Merscher, PhD

1R01 HL128714 (NIH/NHLBI) 07/2015 – 06/2020
Activation of Cardiac FGFR4 Causes Left Ventricular Hypertrophy
Principle Investigator: C. Faul, PhD

1-16-IBS-087 American Diabetes Association Innovative Basic Science Award01/2016 – 12/2018
FGF21 Causes Left Ventricular Hypertrophy
Principle Investigator: C. Faul, PhD

American Heart Association PostDoctoral Award 07/2014 – 06/2016
Cardiac FGFR4 activation causes Left Ventricular Hypertrophy
Principle Investigator: A. Grabner, Mentor: C. Faul, PhD

F31 DK102361 (NIH/NIDDK) 09/2014 – 08/2017
Activation of Protease-Activated Receptor 2 by Zonulin Regulates Cell-Cell Contact
Principle Investigator: K. Schramm, Mentor: C. Faul, PhD

F31 DK09566101 (NIH/NIDDK) 07/2012 – 06/2017
The Role of NFAT in Podocyte Damage and Proteinuric Kidney Disease
Principle Investigator: A. Sloan, Mentor: C. Faul, PhD

F30 DK0910572010 (NIH/NIDDK) 09/2010 – 06//2015
Ruth L. Kirschstein Individual National Research Service Award Career Development Grant
The Role of FGF23 in the Pathogenesis of Chronic Kidney Disease
Principle Investigator: A. Amaral, Mentor: C. Faul, PhD

Diabetes Complication Consortium (NIH/NIDDK) 06/2013 – 05/2014 
Role of Podocyte Lipids in the Prediction of Diabetic
Principle Investigator: A. Fornoni, MD PhD

Diabetes Research Institute Foundation 06/2013 – 05/2014
Lypotoxicity and autoimmunity in Type 1 diabetes.
Principle Investigator: S. Merscher, PhD

The Stanley J. Glaser Foundation Research Award 06/2013-05/2014
SMPDL3b interferes with avb3 integrin signaling in podocytes
Principle Investigator: S. Merscher, PhD

Carl W. Gottschalk Research Scholar Grant 07/2012-06/2014
American Society of Nephrology (ASN)
The role of Fibroblast Growth Factor 23 in Cardiorenal Syndrome
Principle Investigator: C. Faul, PhD

U3 Pharma 06/2012 – 06//2014
Anti-FGFR4 antibodies as a novel therapy to attenuate cardiac disease
Principle Investigator: C. Faul, PhD

Young Investigator Award 12/2013 – 11//2014
Roche, Translational & Clinical Research Center (TCRC), Inc.
Pathologic effects of FGF23 in Chronic Kidney Disease
Principle Investigator: A, Grabner, MD, Mentor: C. Faul, PhD

1UL1TR000460 CTSI/NIH Pilot Study Grant 01/2013 – 12/2013 
Personalized podocyte biology for the prediction of diabetic kidney disease in high risk populations
Principle Investigator: A. Fornoni, MD PhD

Diabetes Research Institute Foundation 06/2014 – 05/2015
Co-Principle Investigator: A. Fornoni, MD PhD

American Heart Association 07/2012 – 06/2013
Role of nephrin deficiency in the mouse pancreas
Sponsor: A. Fornoni, MD PhD

UM CTSI Pilot Award 07/2014 – 06/2015
Mycophenolate Mofetil (MMF) in the Treatment of Type 2 Diabetic Nephropathy (T2DN) in Hispanics and African Americans
Principle Investigator: A. Nayer, MD

The Stanley J. Glaser Foundation Research Award 08/2014-07/2015
The Role of Fibrobast Growth Factor 23 in Cardiac Disease
Principle Investigator: C. Faul, PhD