Clinical Trials

Status: Active – Recruiting to begin soon 
Efficacy and Safety Study to Evaluate Vadadustart for the correction of Anemia in subjects with Non-Dialysis-Dependent Chronic Kidney Disease
Purpose: To demonstrate the efficacy and safety of vadadustat versus darbepoetin alfa for the correction of anemia in subjects with non-dialysis dependent chronic kidney disease
ClinicalTrials.gov Identifier: NCT02648347
Primary/Site/Co Investigator: Jeffrey Rimmer, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Information on this trial: Clinicaltrials.gov

Status: Active – Recruiting
FIDELIO Study
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Purpose: The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
ClinicalTrials.gov Identifier: NCT02540993
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Information on this trial: Clinicaltrials.gov

Status: Active – Recruiting
FIGARO Study
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Purpose: The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
ClinicalTrials.gov Identifier: NCT02545049
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Information on this trial: Clinicaltrials.gov
Status: Active – Recruiting
FIDELIO Study
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Purpose: The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
ClinicalTrials.gov Identifier: NCT02540993
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Information on this trial: Clinicaltrials.gov
Status: Active – Recruiting
FIGARO Study
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Purpose: The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
ClinicalTrials.gov Identifier: NCT02545049
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Information on this trial: Clinicaltrials.gov
Status: Active – Recruiting
CREDENCE Study
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
Purpose: The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
ClinicalTrials.gov Identifier: NCT02065791
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Information on this trial: Clinicaltrials.gov
Status: Active – Recruiting
SONAR Study
Study of Diabetic Nephropathy with Atrasentan
Purpose: The study objective is to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine or the onset of end stage renal disease (ESRD) in subjects with type 2 diabetes and nephropathy who are treated with the maximum tolerated labeled daily dose (MTLDD) of a Renin Angiotensin System (RAS) inhibitor.
ClinicalTrials.gov Identifier: NCT01858532
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Information on this trial: Clinicaltrials.gov
Status: Active – Recruitment on hold
Endothelial function in subjects with kidney disease
Purpose: The purpose of the study is to determine whether a device called Endothelix VENDYS® monitor can be used to diagnose and monitor treatment of problems of blood vessel function in patients with kidney disease.
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC 802-847-4095
Status: Active – No Longer Recruiting
Open-label Tolvaptan Extension Study
Purpose: The purpose of the study is to evaluate and describe the long term safety of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD).
ClinicalTrials.gov Identifier: NCT02251275
Primary/Site/Co Investigator: Alan Segal, M.D.
Contact: Penny Fairhust, RN, CCRC, 802-847-4095
Status: Active – Enrolling by Invitation Only
The use of Licox O2 monitoring technology for determining which patients undergoing cardiopulmonary bypass are at risk for acute kidney injury
Purpose: To help determine which patients undergoing cardiopulmonary bypass are at a higher risk for developing an acute kidney injury.
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhurst, RN, CCRC, 802-847-4095
Status: Study is closed
REPRISE Study
Purpose: The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
ClinicalTrials.gov Identifier: NCT02160145
Primary/Site/Co Investigator: Alan Segal, M.D.
Contact: Penny Fairhust, RN, CCRC, 802-847-4095
Information on this trial: clinicaltrials.gov
Status: Study is closed
Gilead Study
Efficacy, Safety, and Tolerability of GS-4997 in Participants With Diabetic Kidney Disease
Purpose: This study will evaluate the efficacy, safety, and tolerability of GS-4997 in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of GS-4997 (2 mg, 6 mg, or 18 mg) or matching placebo.
ClinicalTrials.gov Identifier: NCT02177786
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhust, RN, CCRC, 802-847-4095
Information on this trial:  clinicaltrials.gov
Status: Active – Not Recruiting
CKDopps Study
Chronic Kidney Disease Outcomes and Practice Patterns Study
Purpose: To provide important information to help improve care and outcomes for people with kidney disease around the world.
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhust, RN, CCRC, 802-847-4095
Status: Study is closed
Symplicity HTN-3 Study
Renal Denervation in Patients With Uncontrolled Hypertension
Purpose: The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
ClinicalTrials.gov Identifier: NCT01418261
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhust, RN, CCRC, 802-847-4095
Information on this trial:  clinicaltrials.gov
Status: Active – Not Recruiting
FAHC Quality Improvement Project with Cardiothoracic Surgery to Minimize AKI post CABG
Purpose: pending
ClinicalTrials.gov Identifier: tbd
Primary/Site/Co Investigator: Richard Solomon, M.D.
Contact: Penny Fairhust, RN, CCRC, 802-847-4095
Information on this trial: pending