Clinical trials

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.

Complexa FSGS Study

• 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.

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
  • 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

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 immunomodulatory 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).

Duplex FSGS Study

• 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.

NEPTUNE (The Nephrotic Syndrome Study Network)

• 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

Omeros IgA Study

• 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.

Staged PKD

• Name of PI and Coordinator:
  Simin Goral, MD, Debbie Grier, BSN, RN, MBA, CCRP
• Contact:
  Debbie Grier – Debbra.Grier@uphs.upenn.edu, 215-615-4938
• Purpose of Study/Patient Population: Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of an investigational new drug in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) The purpose is to determine the effect of an investigational new drugon rate of renal function (eGFR)decline as compared to placebo in patients at risk of rapidly progressive ADPKD. The study is divided into 2 stages.

HTN and obesity – management of hypertension in obesity

• Name of PI and Coordinator:
  Jordy Cohen, MD, Elkys Funez, Shira Blady
• Contact:
  Elkys Funez – Elkys.Funez@uphs.upenn.edu
• Purpose of Study/Patient Population: Antihypertensive class effects, blood pressure control, and renal and cardiac outcomes—The goal of this study is to evaluate the effect of obesity and body fat distribution on how blood pressure medication classes impact degree of blood pressure control.

Radiance-HTN TRIO

• Name of PI and Sub I:
  Debbie Cohen, MD and Maria Bonanni, NP 
• Contact Coordinator:
  Jaldhi Patel, Jaldhi.Patel@pennmedicine.upenn.edu, 215-615-4886

Purpose of Study/Patient Population:

High blood pressure is also known as “hypertension.” The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension. Renal denervation utilizing the Paradise system uses therapeutically heated ultrasound energy to disrupt nerve activity by either disabling or destroying the nerves that provide signals to the kidney and may lower blood pressure. 

Study Description

TRIO CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of three or more antihypertensive medications. Looking for 150 participants.

Duration: Enrollment in the study will continue until market approval or 150 subjects have been treated, whichever occurs first. All subjects undergoing ultrasound renal denervation will be followed for 5 years (60 months) following the study procedure.

Main Inclusion Criteria:

1. Age ≥18 and ≤75 years at time of consent of any gender
2. Documented history of hypertension with minimum 3 anti-hypertensive medications
3. Average seated office BP ≥140/90 mmHg at screening visit (V0) despite taking stable doses of three or more antihypertensive medications, including a diuretic, for at least 4 weeks prior to consent
4. Documented daytime ABP ≥135/85 mmHg following 4-week stabilization period on standardized antihypertensive medication regimen
5. Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in subjects without a recent (≤1 year) renal imaging)
6. Able and willing to comply with all study procedures

Main Exclusion Criteria:

1. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥9.0%)
2. Secondary hypertension not including sleep apnea
3. Documented history of chronic active inflammatory bowel disorders such as Crohn’s disease or ulcerative colitis
4. eGFR of < 40 mL/min/1.73 m^2
5. Night shift workers
6. Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
7. Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of childbearing potential)

SPYRAL HTN-OFF MED

• Name of PI, Sub I and Coordinator:
  Debbie Cohen, MD, Yonghong Huan, MD, Matt Denker, MD, Robin Neubauer, RN
• Contact:
  Robin Neubauer, RN – Robin.Neubauer@uphs.upenn.edu, 215-615-0773
• Purpose of Study/Patient Population:
  The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients who are currently not taking medications for high blood pressure.

SPYRAL HTN-ON MED

• Name of PI, Sub I and Coordinator:
  Debbie Cohen, MD, Yonghong Huan, MD, Matt Denker, MD; Robin Neubauer, RN
• Contact:
  Robin Neubauer – Robin.Neubauer@uphs.upenn.edu, 215-615-0773
• Purpose of Study/Patient Population:
  The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients whose blood pressure is not controlled, despite treatment with three blood pressure medications.

Friends & Family of Kidney Transplant Patients (FFKTP)

Co-Principal Investigators: Peter Reese, MD, PhD and Jonathan Daw, PhD (PSU)

Sponsor: National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)

FFKTP is a multicenter study to collect novel data on transplant candidates' social networks and to test promising social interventions that could reduce barriers to living donation donor kidney transplant.

CRC: Brian McCauley, Clinical Research Coordinator
Email: Brian.Mccauley2@pennmedicine.upenn.edu
Phone: 570-223-4412

Exploring Caregiver Perspectives on HCV+ KTx

Principal Investigator: Peter Reese, MD, PhD

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The purpose of this study is to utilize qualitative methods to explore the perceptions and decision-making processes of caregivers for HCV+ kidney transplant patients on the waitlist and posttransplant.

CRC: Sabrina Emms, Clinical Research Coordinator
Email: Emmss@pennmedicine.upenn.edu
Phone: 570-506-0108

Transplanting Hepatitis C Kidneys Into Negative KidnEy Recipients (THINKER-NEXT)

Co-Principal Investigators: Peter Reese, MD, PhD, Therese Bitterman, MD, and Douglas Schaubel, PhD

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The THINKER-NEXT Study will provide Hepatitis C Virus (HCV) infected kidneys to people on the kidney transplant waiting list who do not have HCV, then cure the HCV infection with an antiviral drug with the goal of making more kidneys available to people on the waiting list.

CRC: Uma Krishnan, Clinical Research Coordinator
Email: Uma.Krishnan@pennmedicine.upenn.edu
Phone: 215-746-2484

PTAAK — Study of Pulse Wave Velocity Evaluation Tacrolimus Time in Therapeutic Range and Co-efficient of Tacrolimus Variation of African American Kidney Transplant Recipients Receiving immediate Release Tacrolimus Capsules (IR-Tac) or Extended Release Tacrolimus Tablets (LCPT)

The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the patient is taking either Envarsus XR® (extended release tacrolimus) tablets administered once-daily after transplantation or immediate release generic tacrolimus capsules that are administered twice-daily after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well patients’ blood vessels adapt to each heartbeat. Patients will remain in the study for up to 18 months during which time they will be seen for monthly clinic visits, and complete labs per the standard of care.

Co-Principal Investigators: Jennifer Trofe-Clark, Pharm D and Roy Bloom, MD

Sponsor: Veloxis Pharmaceuticals

Study team: Lindsay O’Rourke (Lindsay.O'Rourke@pennmedicine.upenn.edu)/215-615-0773;
Ingrid Thone (Ingrid.Thone@pennmedicine.upenn.edu)/215-220-9510

A Randomized Study to Evaluate Antibody Response to an Additional Dose of SARS-CoV-2 Vaccination With and Without Immunosuppression Reduction in Kidney and Liver Transplant Recipients

The purpose of this study is to help us learn whether an additional dose of COVID-19 study vaccine with or without lowering an anti-rejection medicine can help transplant recipients make more antibody to COVID-19. This study will enroll kidney or liver recipients at least 12 months post-transplant who have received 2-4 doses of the Moderna or Pfizer COVID-19 vaccine at least 30 days ago.

Principal Investigator: Emily Blumberg, MD

Sponsor: NIH

Contact: Maryann Najdzinowicz, Clinical Research Nurse
Email: Maryann.Najdzinowicz@pennmedicine.upenn.edu
Phone: 215-662-4007

Kidney Transplantation in Recipients and Donors with HIV: Long Term Follow up Study

The purpose of this study is to evaluate long-term outcomes in transplant recipients with HIV who receive kidneys from donors with HIV compared to donors without HIV.

Principal Investigator: Emily Blumberg, MD

Sponsor: Johns Hopkins University

Contact: Maryann Najdzinowicz, Clinical Research Nurse
Email: Maryann.Najdzinowicz@pennmedicine.upenn.edu
Phone: 215-662-4007

A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp versus Intravenous Echinocandin followed by Oral Fluconazole

The purpose of this study is to compare oral ibrexafungerp to the current standard antifungal treatment (oral fluconazole, oral voriconazole, or IV Caspofungin)

Principal Investigator: Emily Blumberg, MD

Sponsor: Scynexis

Contact: Maryann Najdzinowicz, Clinical Research Nurse
Email: Maryann.Najdzinowicz@pennmedicine.upenn.edu
Phone: 215-662-4007

An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA ≥99.9%) Kidney Transplant Patients with Positive Crossmatch Against a Deceased Donor, Comparing Desensitization Using Imlifidase with Standard of Care

Principal Investigator: Ronald Parsons, MD

Sponsor: Hansa Biopharma AB

The purpose of this study is to demonstrate the efficacy and safety of imlifidase in comparison to the standard of care (SoC) in the management of highly sensitized transplant patients. If you decide to take part in this study, you will be randomly assigned (much like the flip of a coin) to treatment with either investigational imlifidase or SoC. SoC management means desensitization according to the standard treatment options available at the hospital or waiting for a more compatible organ offer.

Contact: Hercys Sanchez Rodriguez, Research Coordinator
Email: Hercys.SanchezRodriguez@pennmedicine.upenn.edu
Phone: 215-410-9378

A Dose Escalation and Proof-of-Concept Study of REGN459 or REGN5458 (BCMA x CD3 Bispecific Antibodies) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen