Clinical Studies & Trials

LHI Clinical Trials

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.

CLINICAL TRIALS

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

Type 2 diabetes is the most common type of diabetes, affecting almost 10% of the population. Patients with diabetes are at increased risk of kidney disease and make up almost 50% of the new cases of end-stage kidney disease in the US. Nidufexor is a new agent that acts on a bile acid receptor in the liver, potentially reducing fibrosis and inflammation.  This may have the potential to delay diabetic kidney disease in patients with diabetes. The aim of this study is to test if Nidufexor is safe, well tolerated and efficacious in patients with type 2 diabetes.  This study is sponsored by Novartis.

Eligibility to participate

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

• Are between the ages of 18 – 75 years
• Have type 2 diabetes
• Are concerned you may have or may develop kidney problems related to diabetes

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

What is involved in the Study?

• Participants will be randomly assigned to take Nidufexor or a placebo (inactive pill) for 32 weeks.
• During this time, participants will periodically have follow up visits at the University of Minnesota.

Principal Investigator
Luiza Caramori, MD, PhD, MSc

More Information
(612) 301-6685

CLINICALTRIALS

Patients with type 1 diabetes remain at risk for end-stage renal disease despite improvements in blood pressure and blood glucose control. The PERL study was a three-year multi-center study funded by the National Institutes of Health (NIH) aiming to determine whether allopurinol could reduce loss of renal function in people with type 1 diabetes.  This study is now completed, and patient who enrolled in PERL are currently participating in PERLage, PERL follow-up study, and/or in the PERL Kidney Biopsy study, a PERL Ancillary study (see below).

Ancillary Studies

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.  Only patients who participate in PERL are eligible for this study.Measuring GFR using Filter Paper

Follow-up Study

PERLage is the non-interventional (no study medication) follow-up of the PERL trial.  Patients who were recruited in PERL have an annual follow-up evaluation to determine the course of kidney, heart and eye disease as it relates to diabetes.  Only patients who participated in PERL are eligible for this study.

Principal Investigator
Luiza Caramori, MD, PhD, MSc

More Information
(612) 301-6685

STUDY WEBSITE    CLINICALTRIALS

GI Division Clinical Studies

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

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
Yvonne Datta, MD

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

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

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

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

Cancer Center Clinical Trials

IDIM Division Clinical Trials

Systolic Blood Pressure Intervention Trial (SPRINT)

Blood Pressure and Kidney Function - SPRINT vs Electronic Health Record Data 

Principal Investigator
Paul Drawz, MD

Program Manager
Nayanjot Kaur Rai, MPH, BDS
rai00041@umn.edu

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

CLINICAL TRIAL

Preventing Cognitive Decline by Reducing BP Target Trial (PCOT)

Principal Investigator
Paul Drawz, MD

Program Manager
Nayanjot Kaur Rai, MPH, BDS
rai00041@umn.edu

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

CLINICAL TRIAL

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

Study Coordinator
Amy Hanson, CCRC
amhanson@umn.edu

CLINICAL TRIAL

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

Co-Investigator
Katti Woerner, 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

APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

Principal Investigator
Samy Riad, MD, MS

Co-Investigator
Richard Spong, MD

Study Coordinator
Ghislaine Feussom
feuss001@umn.edu

CLINICAL TRIAL 

Phase 3

A Randomized, Controlled, Multi-Center, Safety and Efficacy Study of FCR001 Cell-Based Therapy Relative to a Tacrolimus and Mycophenolate-Based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors (FREEDOM-1)

Principal Investigator
Erik Finger, MD, PhD

Co-Investigator
Samy Riad, MD, MS

Study Coordinator
Dave Ankarlo
anka0004@umn.edu

CLINICAL TRIAL 

Immunosuppression Reduction in Failed Allograft Guided by cfDNA

Principal Investigator
Samy Riad, MD, MS

Study Coordinator
Ghislaine Feussom
feuss001@umn.edu

CLINICAL TRIAL

Cf-DNA Assay During Treatment of Acute Rejection-Pilot Study

Principal Investigator
Arthur Matas, MD

Co-Investigators
Samy Riad, MD, MS

Adam Bregman, MD, MBA

Study Coordinators
Marcia Brott
brott001@umn.edu

Amanda Contreras
contr014@umn.edu

CLINICAL TRIAL

Phase 1 and Phase 2 Trial

PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

Principal Investigator
Michelle Rheault, MD

Co-Investigator
Samy Riad, MD, MS

Study Coordinators
Marcia Brott
brott001@umn.edu

Thu Danh, MPH
danhx005@umn.edu

CLINICAL TRIAL

Phase 2 Trial

Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)

Principal Investigator
Patrick Nachman, MD

Study Coordinators

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

Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

The Nephrotic Syndrome Study Network (NEPTUNE)

Principal Investigator
Patrick Nachman, MD

Co-Principal Investigator
Michelle Rheault, MD

Study Coordinators
Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL

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

Phase 3 Trial

A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Principal Investigator
Patrick Nachman, MD

Co-Investigators
Surabhi Thakar, MD 

Parastoo Fazeli, MD

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

CLINICAL TRIAL

Phase 3 Trial

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

Principal Investigator
Surabhi Thakar, MD

Study Coordinator
Mary McDonald, RN, CCRP
mcdo0664@umn.edu

CLINICAL TRIAL