Kidney Disease clinical trials at UCSF

A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

The goal of this clinical trial is to compare two health system-based approaches for offering kidney failure treatment options to older patients with kidney failure, specifically, to ensure patients are actively involved in a shared decision making (SDM) process covering a full range of treatment choices and have meaningful access to that full range of choices. These include standard in-center or home dialysis as well as alternative treatment plans (ATPs): active medical care without dialysis, time-limited trial of dialysis, palliative dialysis, and deciding not to decide. Approach 1 - Educate and Engage: Nephrology practices encourage their patients to a) participate in a kidney disease education program providing a balanced presentation of all options including ATPs, b) use evidence-based patient decision aids that include ATPs, and c) engage in SDM with staff trained in communication skills and best practices. Approach 2 - Educate and Engage Plus Kidney Supportive Care Program: Nephrology practices add a primary palliative care program to support patients who choose ATPs and their families. The program provides care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist. To compare the two approaches, the investigators will conduct a repeated, cross-sectional stepped wedge cluster randomized trial involving 20-25 chronic kidney disease clinics at 8 practice organizations around the United States. Aim 1: Compare the effectiveness of Approaches 1 and 2 in a) increasing proportion of patients choosing ATP and b) reducing patient-reported decisional conflict about treatment. Aim 2: Compare the patient and family experience of ATP care between Approaches 1 and 2 in terms of quality of life, services used, and end of life (EOL) experience. Aim 2a will focus on experience while patients are receiving an ATP. Aim 2b will describe the EOL experience. Aim 3: Evaluate implementation of each approach through a mixed-methods design based on the expanded RE-AIM framework. For Aims 1 and 2, researchers will collect information by chart review and surveys with patients and caregivers. For Aim 3, clinic administrators, clinical providers, and staff will complete pre- and post-test surveys at the beginning and end of each training.

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of <140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.