Clinical Studies & Trials

Our clinical research studies are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, a new drug, diet or medical device is safe and effective. 


CARDIOVASCULAR

Center For Resuscitation Medicine Trials

resuscitation-clinical-researchResuscitation science is a developing sub-specialty of Interventional Cardiology under the leadership of Demetri Yannopoulos, MD. The focus of this center is to conduct research that focuses on all aspects of resuscitation from sudden cardiac arrest. This center will conduct research to answer critical questions about new treatments, innovative medical devices, and strategies for patient management that spans from bystander response, pre-hospital providers, and in-hospital care. The clinical research team includes partnerships with the Lillihei Clinical Research Unit, and the Center for Biometric Research supported by National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114.

Basic Science Laboratory

The laboratory focuses on understanding the mechanisms of cell death that occur during cardiac arrest while also testing various treatment strategies to prevent damage and increase the likelihood of functional recovery. The lab, at the University of Minnesota, is one of the most advanced models to study sudden cardiac death in the nation. Our studies span the fields of biochemistry, molecular biology, cell biology, biomedical engineering, physiology, and medicine. The assembled team is an interdisciplinary group of investigators that are focused on the development of studies that ensure results that can be translated in to patient care models. The expansion of knowledge acquisition will continue to rise from the studies conducted, as a wide spectrum of expertise and capital investment is in place. The team looks forward to continued discoveries and innovative solutions to the problem of sudden cardiac death.

Center for Resuscitation Medicine

The University of Minnesota and Center for Resuscitation Medicine have led several important research initiatives that are dedicated to the development, evaluation, and advancement of novel, lifesaving protocols and technologies. One of the results of this work is that the Twin Cities became the first large metropolitan area with a unified cardiac catheterization laboratory access protocol for patients who experience out-of-hospital cardiac arrest. Partners are also working to develop effective therapies for sudden cardiac arrest. They are testing promising new medications that could protect the heart and brain from cardiac arrest and resuscitation-related injuries. The future holds the potential for a clinical study on a life support therapy that could improve cardio-cerebral outcomes in patients who do not receive bystander CPR and experience prolonged untreated cardiac arrest.

“A strategic approach to implementation of resuscitation science discoveries and new therapies is required to foster evidence adoption, use, and sustainability. Once a new treatment has demonstrated benefit in controlled clinical trials, it must be tested in increasingly realistic settings to confirm effectiveness and to identify the optimal clinical practice protocols. Translational research focuses on the translation of new findings in basic science into new treatments and the adoption of those treatments in practice (Rubio et al., 2010). In the resuscitation field, guidelines are a predominant mechanism for translating research into practice. The rapid translation of basic research findings into new treatments and the adoption of new treatments into practice is more likely if clinical trials and related studies are designed to produce results that can facilitate evidence-based practice.” 

ACCESS TRIAL            ARREST TRIAL

Lillehei Clinical Research Unit (LCRU)

The Lillehei Clinical Research Unit (LCRU) supports the research activities for the Cardiovascular Division clinical faculty at the University of Minnesota. The LCRU is currently conducting approximately 60 clinical trials in various phases of enrollment and follow-up with a mix of investigator initiated, industry sponsored and government sponsored trails.

Active areas of study include: Stem Cell Therapy, Interventional Cardiology, Electrophysiology, Congestive Heart Failure, Heart Transplant, Ventricle Assist Devices, Cardiac Imaging, Pulmonary Hypertension, Primary and Secondary Prevention and Vascular Disease.

CLINICAL TRIALS

 

Diabetes, Endocrinology and Metabolism

Epidemiology of Diabetes Intervention and Complications (EDIC)

The EDIC study is a multicenter, observational study designed to follow the type 1 diabetic volunteers who participated in the Diabetes Control and Complications Trial (DCCT). EDIC has been following subjects since 1994.

This study is currently following participants.

Principal Investigator
John Bantle, MD

More Information
John Bantle, MD
bantl001@umn.edu
(612) 626-0462

CLINICAL TRIALS

Glycemia Reduction Approaches in Diabetes (GRADE)

GRADE Banner

A Comparative Effectiveness Study (GRADE)

What is GRADE?
GRADE is a long-term study of different treatments for type 2 diabetes funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH). Type 2 diabetes is an epidemic that threatens to become the century's major public health problem and poses enormous human and economic challenges worldwide. Most people with diabetes eventually need 2 medications to control blood glucose levels. A major challenge is to determine which of the many possible drugs is the best choice among people already treated with metformin, the most commonly used diabetes drug. GRADE will determine which combination of two medications is best for glycemic control, has the fewest side effects, and is the most beneficial for overall health.

Eligibility to Participate

You may be eligible to participate in the GRADE Study if you:

  • Have type 2 diabetes for 10 years or less
  • Were at least 30 years old at time of diagnosis
  • Are taking no medications for your diabetes or are only taking metformin

This study does not accept healthy participants. This study is currently following participants.

What is involved in the Study?

  • 2 medications taken daily – metformin and a randomly selected second medication at no charge to participant
  • Blood sugar tested up to 2 times daily at home
  • After an initial period, visits to the University of Minnesota every 3 months until the projected end of the study in 2021.
  • Optional participation in 3 related sub-studies

Principal Investigator
Elizabeth Seaquist, MD

Grade Team
grade@umn.edu
(612) 626-0143

GRADE WEBSITE   CLINICAL TRIAL

Hypoglycemia Studies

Naloxone, Hypoglycemia & Exercise

Preventing hypoglycemia after exercise can be difficult. The purpose of this study is to learn if naloxone can be used to treat exercise-related hypoglycemia symptoms. Naloxone is currently used as a substance abuse treatment medication but research studies have shown it to possibly be effective in preventing next-day hypoglycemia.

This study is looking for people who:

  • Are between the age of 18 – 65
  • Have type 1 diabetes for 2 - 30 years
  • Are willing to avoid exercise for the week before the study

This study involves one (1) screening visit where you will ride an exercise bike to determine your V02 max and wear a continuous glucose sensor (CGM). About 1 week later, you will return to the University of Minnesota for one (1) full day and one half (1/2) day visit. At the full day visit, you will ride an exercise bike and be given either naloxone or a placebo. The following day, we will lower your blood sugar to make you hypoglycemic and ask you about your symptoms. You will return about 8 weeks later to repeat the full day and half day parts of the study. If all parts of the study are completed, compensation is up to $675.


Recurrent Hypoglycemia in Type 1 Diabetes

This study has two aims that are currently enrolling subjects

Aim 1 involves one (1) screening visit, wearing a continuous glucose sensor (CGM) and an activity/sleep tracker, and two (2) full day visits to the University of Minnesota Center for Magnetic Resonance Research (CMRR). On each of the full day visits, you will have your blood sugar lowered 2 times and we will take 1 MRI scan of your brain. If all parts of the study are completed, compensation is up to $1,025.

Aim 2 involves one (1) screening visit, wearing a continuous glucose sensor (CGM) and an activity/sleep tracker, and three (3) visits to the University of Minnesota Center for Magnetic Resonance Research (CMRR) or Clinical Research Unit (CRU). On day one visit (CMRR), you will have your blood sugar increased and we will take an MRI scan of your brain. On day 2 (CRU) your blood sugar lowered 2 times and blood samples will be taken. On day 3 (CMRR) your blood sugar will lowered (similar to day 2) and then your blood sugar will be increased and an MRI taken of your brain (similar to day 1). If all parts of the study are completed, compensation is up to $1,300

Preventing Early Renal Function Loss in Diabetes (PERL)

PERL stands for Preventing Early Renal Function Loss in Diabetes. The PERL study is a three-year multi-center study aiming to determine whether allopurinol can reduce loss of renal function in people with type 1 diabetes. Patients with type 1 diabetes remain at risk for end-stage renal disease despite improvements in blood pressure and blood glucose control. Allopurinol is a medication that has been on the market for almost 50 years, has an excellent safety profile, and is used to prevent gout in patients with elevated uric acid levels. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future.

Eligibility to participate

You may be eligible to participate in the PERL study if you:

  • Are between the ages of 18 – 70 years
  • Have type 1 diabetes for at least 8 years
  • Are concerned you may have or may develop kidney problems related to diabetes

This study does not accept healthy participants. This study is currently following participants.

What is involved in the Study?

  • Participants will be randomly selected to take allopurinol or a placebo (inactive pill) for three years.
  • During this time, participants will periodically have follow up visits at the University of Minnesota.
  • Kidney function will be measured at the beginning and at the end of the treatment period

Ancillary Studies

Continuous Glucose Monitoring (CGM)
The purpose of this study is to assess the role of glycemic variability (daily changes in the level of blood glucose) in the progression of kidney disease caused by diabetes in individuals who have mild to moderate kidney disease.

Kidney Biopsy
The purpose of this study is to obtain kidney tissue which, in combination with the data obtained in the main PERL study, will be studied to identify new ways to predict who will develop more serious diabetic kidney disease and identify potential targets for new therapies.

Measuring GFR using Filter Paper
The purpose of this study is to learn more about measuring kidney function with iohexol clearance using a drop of blood from the finger (a finger stick). This less burdensome method to reliably measure iohexol clearance has the potential to significantly enhance how research in diabetic kidney disease, other forms of kidney disease, and eventually clinical care is provided. 

Principal Investigator
Luiza Caramori, MD, PhD, MSc

More Information
(612) 301-2103

STUDY WEBSITE    CLINICALTRIALS

 

Hematology, Oncology and Transplantation

Non-Malignant Hematology Clinical Trials

HEMOPHILIA A

GeneR8-1
A Phase III open-label, single-arm study to evaluate the efficacy and safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene transfer of Human Factor VIII in Hemophilia A patients with residual FVIII levels ≤ 1 IU/dL receiving prophylactic FVIII infusions (BMN 270-301).

Principal Investigator
Mark Reding, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280


HEM-POWR
An observational study evaluating effectiveness and safety of real-world treatment with Damoctocog alfa pegol in previously treated patients with Hemophilia A.

Principal Investigator
Joan Beckman, MD, PhD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

HEPARIN-INDUCED THROMBOCYTOPENIA (HIT)

HITOVA
An open-label, randomized, active controlled, multi-center Phase III study to evaluate the safety and efficacy of Danaparoid vs Argatroban in treatment of subjects with acute HIT. This is a hospital-based study with follow-up.

Principal Investigator
Surbhi Shah, MBBS

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

Polycythemia Vera and Essential Thrombocythemia

Role of endothelial cells in MPN in bleeding and clotting. Non-interventional, observation study to investigate mechanisms of bleeding and clotting in MPN patients. The study collects blood at routine visits. 

Princiapl Invesigator
Joan Beckman, MD, PhD

More Information
Musa Jama
jamax165@umn.edu
(612) 624-5773

PORPHYRIAS

7201:Longitudinal Study of the Porphyrias
The objective of this study is to conduct a longitudinal investigation of the natural history, complications and therapeutic outcomes in people with acute and cutaneous porphyria.

Principal Investigator
Marshall Mazepa, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

Sickle Cell Disease

Sickle Cell and the Endothelium. Non-interventional, observation study to investigate endothelial biomarkers in individuals with Sickle Cell and Sickle Cell trait. The study collects blood at routine visits.

Principal Investigator
Greg Vercellotti, MD

More Information
Muse Jama
jamax165@umn.edu
(612) 624-5773

Thrombotic Thrombocytopenic Purpura (TTP)

USTMA P201
A Pilot Study of Acquired Thrombocytopenic Purpura and Neuropsychologic Complications: A multi-center, prospective, and longitudinal study of neuropsychological complications in patients with acquired TTP in remission.

Principal Investigator
Marshall Mazepa, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280


USTMA P200
United States Thrombotic Microangiopathy (USTMA) Thrombotic Thrombocytopenic Purpura (TTP) Clinical Data and Biologic Sample Repository.  The primary objective of this study is to establish a tissue and clinical data repository of patients diagnosed with thrombotic thrombocytopenic purpura (TTP) for patients that are treated at member institutions of the United States Thrombotic Microangiopathy (USTMA) consortium.

Principal Investigator
Marshall Mazepa, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280


A Phase II, multi-center, randomized, placebo-controlled, double blind study in patients with acquired thrombotic thrombocytopenia purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment.

Principal Investigator
Yvonne Datta, MD

More Information
Amy Eisenberg
eisenbea@umn.edu
(612) 624-9280

 

Nephrology and Hypertension

FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

Phase 3 Trial
A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Principal Investigator
Michelle Rheault, MD

CLINICAL TRIAL

IGA NEPHROPATHY

Phase 3 Trial

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)

Principal Investigator
Surabhi Thakar, MD

Study Coordinators
Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL


Phase 3 Trial

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

Principal Investigator
Patrick H. Nachman, MD

Study Coordinators
Elizabeth Miller, RN, BAN, PHN, CCRC
mill7440@umn.edu

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Phase 2 Trial

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus 

Principal Investigator
Dr. Parastoo Fazeli

Study Coordinator
Julie Scherber
sche0245@umn.edu

CLINICAL TRIAL