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.

Principal Investigator: Roy Bloom, MD

LCP-Tacro 3004

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.

http://www.clinicaltrials.gov/ct2/show/NCT01962922?term=lcp+tacro+3004&rank=1

Enrollment Status:
Open Enrollment

Contact Information:
Jennifer Trofe-Clark, Pharm D
215-614-4274

Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion of Nulojix® (belatacept)-based Immunosuppression.

This study assesses the safety and efficacy of conversion from CNI to belatacept in stable EBV+ adult recipients of a renal allograft from a living donor or a deceased donor between 6-36 months prior to enrollment. Randomized in a 1:1 ratio to treatment with either belatacept or continued treatment with their established CNI.

http://www.clinicaltrials.gov/ct2/show/study/NCT01820572?term=belatacept+conversion&rank=3&show_locs=Y#locn

Enrollment Status:
Open Enrollment

Contact Information:
Roy Bloom, MD
215-615-0773

Principal Investigator: Debbie Cohen, MD

Lifestyle Modification and Blood Pressure Study (LIMBS)

The study is a non-blinded, randomized controlled trial to assess the safety and efficacy of 24 weeks of a structured yoga exercise program (YP) versus a blood pressure education and walking program (BPEP) versus the combined intervention on reducing mild to moderate high blood pressure in adults with pre-hypertension or stage 1 hypertension. This will be done through a single center trial using a parallel design. All potential subjects will be screened first by telephone and then by 2 outpatient visits at the Clinical and Translational Research Center (CTRC) at the Hospital of the University of Pennsylvania. Eligible subjects will then make three visits to the CTRC where they will be admitted overnight to have non-invasive 24-hour recordings of BP, as well as have periodic blood, urine and saliva collections. The entire study duration is 28 weeks (24 weeks post-randomization) and includes a total of seven evaluation visits (including two functional magnetic resonance imaging visits) and a termination visit. Subjects will be randomized to YP, BPEP or the combined intervention of YP and BPEP.

http://clinicaltrials.gov/show/NCT00964847

Contact Information:
Anna Bowler, BA
215-615-6570
anna.bowler@uphs.upenn.edu

Principal Investigator: Laura Dember, MD

NIH Time to Reduce Mortality in Endstage Renal Disease (TiME) Trial

A large, pragmatic, cluster-randomized clinical trial being conducted through the NIH Health Care Systems Research Collaboratory to determine whether longer hemodialysis sessions have benefits on important clinical outcomes.  The trial will enroll over 6000 patients at 400 dialysis units throughout the United States.  In addition to addressing a fundamental clinical question about dialysis care, the trial serves as a model for pragmatic trials that use a highly centralized and efficient implementation approach that leverages the infra-structure of dialysis provider organizations and relies exclusively on data collected through routine clinical care.

https://www.nihcollaboratory.org

http://www.clinicaltrials.gov/ct2/show/NCT02019225

Enrollment Status:  
Recruiting

Contact Information:
Denise Cifelli, MS 
cifelli@mail.med.upenn.edu

NIH Hemodialysis Novel Therapies Consortium Studies

The Data Coordinating Center of the Hemodialysis Novel Therapies (HDNT) Consortium, sponsored by NIDDK, is conducting several early phase multicenter clinical trials of novel therapies to improve outcomes for patients treated with maintenance hemodialysis. The long-term goal is to identify promising interventions for evaluation in large clinical trials. The interventions being studied initially target cardiac fibrosis and inflammation.

Enrollment Status:  
Not yet enrolling

Contact Information:
Tamara Howard, MPH
howardta@mail.med.upenn.edu

NIH Hemodialysis Fistula Maturation (HFM) Study

A multicenter, observational cohort study sponsored by NIDDK and designed to elucidate predictors and underlying mechanisms of hemodialysis arteriovenous fistula maturation. Study participants undergoing fistula creation are studied pre-, intra-, and postoperatively with collection of comprehensive clinical, imaging, functional, and pathologic data to evaluate a broad range of mechanistic hypotheses.

Enrollment Status:  
No longer recruiting (enrollment closed)

Contact Information:
Laura Dember, MD
laura.dember@uphs.upenn.edu

Principal Investigator: Harold Feldman, MD

NIH's Chronic Renal Insufficiency Cohort Study (CRIC)

An NIH-funded "Framingham-like" study of chronic kidney disease. Recruitment is open until July 2015. Our goal is to enroll people with detectable protein in the urine, with or without diabetes. Visits are once a year, and we reimburse patients for their time and travel. Call 215-662-2962 to contact a Recruitment Coordinator for more information.

http://www.cristudy.org

Enrollment Status:
Open through July, 2015

Contact Information:
Wanda Seamon
866-589-2742
wanda.seamon@uphs.upenn.edu

Principal Investigator: Lawrence Holzman, MD

NEPTUNE: Nephrotic Syndrome Study Network

Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately twelve percent of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the U.S. of more than three billion dollars. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD/FSGS and MN biology, it is not surprising that that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients. In response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium. Through this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.

http://clinicaltrials.gov/ct2/show/NCT01209000?term=neptune&rank=1

http://www.neptune-study.org/

Enrollment Status:
Open enrollment

Contact Information:
Krishna Kallem
484-358-0315
krishna.kallem@uphs.upenn.edu

CureGN

Cure Glomerulonephropathy (CureGN) is a multicenter five-year cohort study of glomerular disease patients funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes for Health (NIH). The CureGN project will study 2,400 children and adults with the following glomerular diseases: minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), and IgA nephropathy (IGAN). Participants will be followed longitudinally to better understand the causes of disease, response to therapy, and disease progression, with the ultimate objective to cure glomerulonephropathy.

https://curegn.org

Enrollment Status:
Closed. Enrollment Will Begin Shortly at the Pearlman Center For Advanced Medicine at the University of Pennsylvania.

Duet (Retrophin)

This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).

http://clinicaltrials.gov/ct2/show/NCT01613118?term=retrophin&rank=1

Enrollment Status:
Open enrollment is available at the Pearlman Center For Advanced Medicine at the University of Pennsylvania.

Contact Information:
877-659-5518
medinfo@retrophin.com

A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

The primary objectives of this trial are to:

  • Compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo
  • Compare the safety profile of patients treated with fresolimumab versus placebo

http://clinicaltrials.gov/ct2/show/NCT01665391?term=fsgs&rank=2

Enrollment Status:
Not recruiting participants.

Principal Investigator: Yonghong Huan, MD

A Phase 2, single-blind, randomized, controlled, multi-center study to evaluate the efficacy and safety of SRM003 (Vascugel®) in improving the rate of arteriovenous fistula maturation and use in subjects undergoing surgery for creation of an arteriovenous fistula for hemodialysis access.

This study evaluates the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.

ClinicalTrials.gov Identifier: NCT01806545

http://clinicaltrials.gov/ct2/show/NCT01806545?term=NCT01806545&rank=1

A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in the Treatment of Subjects With Vascular Injury Resulting From Arteriovenous Graft Surgery for Hemodialysis Access

This study evaluates the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.

ClinicalTrials.gov Identifier: NCT01806584

http://clinicaltrials.gov/ct2/show/NCT01806584?term=NCT01806584&rank=1

Principal Investigator: Jonathan Maltzman, MD

Immunity to Cytomegalovirus as a Biomarker

Cytomegalovirus (CMV) increases morbidity and mortality post-solid organ transplantation. The primary purpose of this observational study is to analyze the ability of immune cells to respond to CMV. This will be accomplished via measurement of the specificity and polyfunctionality of CMV-specific memory T cells. This information will then be used to determine if CMV-specific T cell profiles pre-transplant can predict the risk of developing CMV recurrence.

Enrollment Status:
Open enrollment.

Contact Information:
Robin Neubauer
215-615-0773

Principal Investigator: Raymond Townsend, MD

Chronic Renal Insufficiency Cohort (CRIC) study

An NIH funded "Framingham-like" study of chronic kidney disease.  Recruitment is open until July 2015.

http://www.cristudy.org

 

Enrollment Status:
Open through July, 2015

Contact Information:
Robin Neubauer
215-615-0773

Systolic Blood Pressure Intervention Trial (SPRINT)

We are conducting the Systolic Blood Pressure Intervention Trial (SPRINT), an NIH sponsored study of different blood pressure goals.

http://www.sprinttrial.org

 

Enrollment Status:
Closed.

Principal Investigator: Peter Reese, MD

Process vs. Outcomes Trial

Behavioral economic approaches, including financial incentives, have been shown to help patients improve medication adherence. This project will determine whether financial incentives are more successful at helping patients lower their cholesterol level when the incentives are given as a daily reward for taking cholesterol medications (process) versus given as a reward for achieving a lower cholesterol (an outcome).

http://clinicaltrials.gov/ct2/show/NCT01798784

Enrollment Status:
By invitation only.

Social Forces to Improve Statin Adherence

The time between healthcare visits is extremely important and leveraging social forces may lead to improved health behaviors. We want to assess the effectiveness of reporting statin adherence patterns to a Medication Adherence Partner (MAP) and in comparison to patient-peers in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle.

http://clinicaltrials.gov/ct2/show/NCT02018809

Enrollment Status:
By invitation only.

Medication Adherence in Kidney Recipients Using Reminders and Provider Notification

Novel wireless technology has created inexpensive tools that allow both accurate monitoring of adherence to pills as well as real-time interventions such as automated reminders in the event of a missed dose. In this study, the investigators will use an electronic pill bottle that, at the prescribed times, will electronically transmit whether a subject opened the pill cap to take the immunosuppressant medication via a built-in transmitter to the central server.

http://clinicaltrials.gov/ct2/show/NCT01541384

Enrollment Status:
Closed.

Phosphorus Control in Dialysis Patients (Pilot)

Derangements in mineral metabolism are nearly universal in ESRD patients on dialysis and elevated PO4 is associated with a greater risk of death and CV events. A substantial percentage of dialysis patients have high serum PO4 due to poor adherence to PO4 binder medications and consumption of high-PO4 foods. This pilot RCT will compare the efficacy of financial incentives vs. coaching vs. usual care over 2 months for improving PO4 levels among 30-40 dialysis patients with high PO4 levels.

Enrollment Status:
Closed.