Clinical Trial Research

Our division participates in various clinical trials to improve the care of kidney disease, including glomerular disease, transplantation, chronic kidney disease, hypertension, and dialytic therapies. Please review the information below about the specific trials. Of note, active patient enrollment in some of the trials has ended. 

Kidney Transplant

FREEDOM-1 Study (A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation)

Aim: This is a Phase 3 clinical trial of FCR001, an investigational cell therapy. The purpose of this study is to learn more about whether FCR001 can prevent the rejection of living donor kidney transplants without the need for lifelong anti-rejection drugs.

Patient Population: Adults age 18-60 with a suitable living kidney donor receiving their first kidney transplant may qualify. Exclusion criteria exist and include a history of cancer.

Contact: Email Christine Hurst, RN More information is available on the study website and the NIH Registry of Trials website.

Diabetic Kidney Disease

TRIDENT (Transformative Research in Diabetic Nephropathy)

Aim: To understand the clinical and molecular basis of progressive diabetic kidney disease.

Patient Population: Adults with Type 1 or Type 2 diabetes who need a kidney biopsy.

Contact: Please review with your kidney doctor. More information is available on the study website and the NIH Registry of Trials website.

Dialysis and Bloodstream Infections

GARNET™ Filter Feasibility of Hemodialysis With the GARNET Device in Chronic Hemodialysis Patients With a Bloodstream Infection 

Aim: This is an initial study to evaluate the feasibility of hemodialysis using the GARNET device over two dialysis sessions. This is designed to perform traditional hemodialysis in addition to binding pathogens and pathogen-associated molecular patterns (PAMPs) to clear them from the bloodstream, potentially improving infection treatment. 

Patient Population: Hospitalized adults (age 18-90) receiving chronic outpatient hemodialysis with a suspected or confirmed bloodstream infection. Exclusion criteria exist and include pregnancy as well as severe concomitant diseases.

Contact: Email Raghav Wusirika, MDMore information is available on the NIH Registry of Trials website.

Hypertension

SPYRAL (Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy)

Aim: This is a multinational randomized placebo-controlled clinical trial investigating the effectiveness of a procedural intervention (renal denervation) to lower blood pressure. This procedure is designed to block the connection between the nervous system and the kidney in order to reduce blood pressure.

Patient Population: Adults age 20 to 80 with uncontrolled blood pressure despite taking 1, 2, or 3 medications. Exclusion criteria include advanced kidney disease (eGFR < 45 mL/min), Type 1 “Juvenile” diabetes, use of NSAIDs two or more days a week, and recent serious cardiac events.

Contact: Patients can read about the study and take a survey to see if they may qualify on the study website. Patients can request to be contacted by a research coordinator if they may qualify. More information is available at the NIH Registry of Trials website.

IgA Glomerular Disease - Completed Enrollment

NEFIGARD (Nefecon in Patients With Primary IgA Nephropathy at Risk of Progressing to End-stage Renal Disease)

Aim: To evaluate the efficacy of a minimally absorbed oral steroid, budesonide (Nefecon), for the treatment of IgA Nephropathy.

Patient Population: Adults with IgA Nephropathy. 

Contact: The study has completed enrollment. More information is available on the study website and the NIH Registry of Trials website

Chronic Kidney Disease - Completed Enrollment

EAGLE (An Extended Access Program for Bardoxolone Methyl in Patients with CKD)

Aim: To assess the long-term safety of bardoxolone methyl in patients who participated in a clinical study of bardoxolone methyl.

Patient Population: Patients who previously participated in a study using bardoxolone methyl

Contact: The study has completed enrollment. More information is available at the NIH Registry of Trials website

Finding Clinical Trials

Some patients may wish to explore clinical trials outside of OHSU. The websites below may help patients find a relevant trial. Please review your care and potential interest in any study with your kidney doctor. Of note, these websites are not curated by OHSU Nephrology and information may at times be outdated or incorrect.