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.
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.
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.
Autoimmune Kidney Disease
Kidney Disease Biorepository
Aim: This is a patient database that stores clinical information, kidney biopsy specimens, and blood/urine samples from patients with, or at risk for, autoimmune kidney disease. This data will be used in future research focused on understanding the diagnosis, prognosis, and treatment of autoimmune kidney conditions.
Patient Population: Adults age 18-89 who have autoimmune kidney disease, or are at risk for autoimmune kidney disease, based on their other medical conditions or medications.
Contact: Email Tatevik Mazmanyan if you are interested in donating blood and urine to this research repository.
Portland VA Trial - Diabetic Kidney Disease
PTXRX (Pentoxifylline in Diabetic Kidney Disease)
Aim: To evaluate the effectiveness of pentoxifylline in diabetic kidney disease.
Patient Population: Adults with type 2 diabetes and stage 3 or 4 chronic kidney disease. Patients with type 1 diabetes, non-diabetic kidney disease, or severe chronic health conditions are excluded.
Contact: This is a VA trial only. Please review with your kidney doctor. More information is available on the NIH Registry of Trials website.
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, lack of diastolic hypertension (DBP > 90), and recent serious cardiac events. BP medications can be adjusted to allow enrollment in the trial if desired by the patient and provider.
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.
Dialysis and Bloodstream Infections - Completed Enrollment
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.
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.
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.