Penn Kidney

Nephrology Clinical Trials

Clinical trials are research studies (involving patient volunteers) often conducted to find safe and effective treatments for a variety of health conditions. Participating in Renal-Electrolyte and Hypertension clinical trials offers patients the opportunity to try new treatments that could potentially improve their condition while taking part in vital research that can benefit future patients.

Diabetic Nephropathy

Credence: A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
  • Name of PI and Coordinator:
    • Debbie Cohen, MD
    • Robin Neubauer, RN
    • Carla Rivera, CRC
  • Contact:
  • Type of Study:
    Interventional, phase 4
  • Purpose of Study:
    Diabetic Nephropathy — The purpose of this study is to find out if canagliflozin (invokana) has a renal and cardiovascular protective effect to reduce the progression of diabetic kidney and heart disease compared to placebo drug. After screening and run-in, there are 4 visits in 26 weeks, then every 26 weeks thereafter.
  • Inclusion:
    Man or woman >30 years-old with a clinical diagnosis of T2DM, HbA1c between 6.5% to 10.5%, eGFR >30 to <90 mL/min/1.73m2, UACR >300 mg/g to <5000 mg/g, must on a maximum tolerated labeled daily dose of ACEi or ARB for at least 4 weeks prior to randomization.
  • Exclusion:
    Type 1 diabetes mellitus, Known medical history or clinical evidence suggesting non-diabetic renal disease, Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant, Uncontrolled hypertension (systolic BP >180 and/or diastolic BP >100 mmHg)
Pyridorin: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin™ (pyridoxamine dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes
  • Name of PI and Coordinator or Recruiter:
    • Simin Goral, MD
    • Debbie Grier
    • Carla Rivera, CRC
  • Contact:
  • Type of Study:
    Interventional, phase 3
  • Purpose of Study/Patient Population:
    Diabetic Nephropathy. The purpose of this research study is to determine if Pyridorin (pyridoxamine dihydrochloride) can safely slow progression of kidney disease in patients with nephropathy due to type 2 diabetes. Pyridorin is a naturally occurring B6 family metabolite that is normally present at extremely low levels in humans.
  • Inclusion:
    Patients 18 years of age or older with a diagnosis of type 2 diabetes; must have a history of overt diabetic nephropathy, as defined by the following:
    • A SCr measurement ≥1.3 mg/dL (115 μmol/L) for females or ≥1.5 mg/dL (133 μmol/L) for males
    • A 24-hour urine collection PCR ≥1200 mg/g (136 mg/mmol)
    Patients must have an eGFR of ≥20 mL/min/1.73m2, using the 4-variable Modification of Diet in Renal Disease equation, Patients must be taking a single ACE-I or ARB at a constant dose for at least 26 weeks prior to Visit 1, where the dose of the ACE-I or the ARB is considered appropriate for that patient and it is anticipated that the same dose can and will be maintained throughout the course of the study; if not on a stable dose of ACE or ARB, may enter pharmaco-stabilization phase.
  • Exclusion:
    • Patients with type 1 diabetes
    • Patients with a diagnosis of chronic kidney disease other than diabetic renal disease with or without hypertensive renal disease
    • Patients receiving a renin inhibitor or an aldosterone antagonist or a combination of an ACE-I and an ARB within 26 weeks of Visit 1
    • Patients with a history of solid organ transplantation

Kidney Transplant

CMV: Immunity to cytomegalovirus as a biomarker
  • Name of PI and Coordinator or Recruiter:
    • Jonathan Maltzman, MD
    • Robin Neubauer, RN
    • Jennifer Trofe-Clark, PharmD
  • Contact:
    • Robin Neubauer, RN
      215-615-0773
      610-659-2424
  • Type of Study:
    Prospective observational cohort study. Blood draws will take place: Day -1 (pre-transplant); 1 month, 3 months, 6 months, 9 months and 12 months post-transplant. Additional blood will be drawn during any documented episode of CMV viremia. No more than 2 research related blood draw will take place during any 30 day period. Routine patient information will also be collected from electronic medical records corresponding to the dates above.
  • Inclusion:
    Adult renal and cardiac transplant recipients who are cmv negative at baseline.
  • Exclusion:
    No specific exclusion criteria except under the age of 18 or considered a vulnerable population
LCP Tacrolimus: A prospective, randomized, open-label, single-center, two sequence, three period crossover study to compare the steady state pharmacokinetics of Once-Daily-Extended Release MeltDose® tacrolimus tablets (LCP-Tacro®) to generic tacrolimus capsules twice daily in stable African American renal transplant patients. LCP Tacro 3004)
  • Name of PI and Coordinator or Recruiter:
    • Jennifer Trofe-Clark, PharmD
    • Roy Bloom, MD
    • Robin Neubauer, RN
  • Contact:
    • Robin Neubauer, RN
      215-615-0773
      610-659-2424
  • Type of Study:
    Phase 3 Interventional study: LCP Tacrolimus study drug
  • Inclusion:
    African American renal transplant patients between ages 18-80, on generic tacrolimus formulations who are 6 months or more post-transplant with tac levels in range of 5-15 ng/mL.
  • Exclusion:
    +bk virus, + DSA, gfr < 25
Nulojix Study: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (belatacept)-based Immunosuppression
  • Name of PI and Coordinator or Recruiter:
    • Roy Bloom, MD
    • Robin Neubauer, RN
    • Jennifer Trofe-Clark, PharmD
  • Contact:
    • Robin Neubauer, RN
      215-615-0773
      610-659-2424
  • Type of Study:
    Phase 3 Interventional study: Nulojix study drug
  • Inclusion:
    Adult renal transplant recipients in receipt of a renal allograft from a deceased or living donor between 6-36 months post txp prior to enrollment, on a stable regimen of CNI (CsA or TAC), with MMF or EC-MPS/MPA and corticosteroids, stable renal function with gfr between > 30- < 75
  • Exclusion:
    EBV negative, txp rejection within 3 months of randomization, donor age < 10 years of age

Glomerular Disease

Observational Studies

FSGS, Minimal Change Disease, IgA Nephropathy, Membranous Nephropathy, Nephrotic Syndrome

Cure GN (For patient with minimal change disease, FSGS, IgA nephropathy and membranous nephropathy)
  • Name of PI and Coordinator or Recruiter:
    • Lawrence B. Holzman, MD
    • Jonathan Hogan, MD
    • Radhakrishna Kallem
  • 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 Nephropahty. 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 erythamatosus (SLE); active malignancy, except non-melanoma skin cancer; active hepatitis B or C infection, defined as a positive viral load
NEPTUNE (The Nephrotic Syndrome Study Network)
  • Name of PI and Coordinator or Recruiter:
    • Lawrence B. Holzman, MD
    • Jonathan Hogan, MD
    • Radhakrishna Kallem
  • 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 vesico-urethral reflux or renal dysplasia); Known systemic disease diagnosis at time of enrollment with life expectancy less than 6 months

Interventional Studies

Focal Segmental Glomerulosclerosis (FSGS)

Duet (Efficacy and Safety of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, In Patients With Focal Segmental Glomerulosclerosis (FSGS): A Randomized, Double-Blind, Active-Control, Dose-Escalation Study)
  • Name of PI and Coordinator or Recruiter:
    • Jonathan Hogan, MD
    • Krishna Kallem
  • Contact:
    Krishna Kallem
    krishna.kallem@uphs.upenn.edu
    484-358-0315
  • Type of Study:
    Interventional, phase 2
  • Purpose of Study/Patient Population:
    To evaluate the safety and efficacy of Sparsentan compared to Irbesartan in patients with FSGS.
  • Inclusion:
    Ages 18-65, Patients with biopsy proven or genetically confirmed FSGS, urine protein > 1g, GFR >30, stable BP, stable electrolytes.
  • Exclusion:
    No active cancer, HIV, HBV, HCV, or transplant.
D-FINE: Vitamin D Supplementation in Glomerular Disease
  • Name of PI and Coordinator or Recruiter:
    • Jonathan Hogan, MD
    • Study Coordinator: Krishna Kallem
  • Contact:
    Krishna Kallem
    krishna.kallem@uphs.upenn.edu
    484-358-0315
  • Type of Study:
    Open label efficacy study on the effects of vitamin D on proteinuria in young patients (up to 30 years old) with FSGS
  • Inclusion:
    Ages 5-30 years, diagnosis of biopsy-proven FSGS, serum 25(OH)D level <20 ng/ml and urine protein:creatinine ratio ≥0.5 at Screening Visit and no new immuno-modulatory agent within prior 3 months of Screening Visit (not including corticosteroid therapy).
  • Exclusion:
    Pregnancy, estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73m2 at Screening Visit, serum phosphorus > 5.5 mg/dl or hypercalcemia, chronic medical conditions or medications unrelated to the renal disease that may impact vitamin D status, known history of kidney stone(s).

Chronic Kidney Disease and Dialysis

CRIC (Chronic Renal Insufficiency Cohort Study)
  • Name of PI and Coordinator or Recruiter:
    • Raymond R. Townsend, MD
    • Wanda M. Seamon, BS (Recruiter)
  • Contact:
    Wanda M. Seamon, BS
    wanda.seamon@uphs.upenn.edu
    215-662-2962
  • Type of Study:
    Observational, Phase III
  • Purpose of Study/Patient Population:
    To identify and follow the progress of people with Chronic Renal Insufficiency (aka Chronic Kidney Disease).
  • Inclusion:
    Age: 45 – 79 and GFR: 45 – 70 with dipstick urine protein ≥ +1
  • Exclusion:
    Polycystic kidney disease, Kidney dialysis, any transplant, HIV/AIDS, Cancer of kidney, Chemo within last 2 years, Immunotherapy for renal disease within past 6 months