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Kidney Disease clinical trials at UC Health
40 in progress, 14 open to eligible people

  • A Comparison Study of the Experimental Human Acellular Vessel For Dialysis in End-Stage Renal Disease

    open to eligible people ages 18 years and up

    The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access

    at UC Davis UC Irvine UCLA UCSD UCSF

  • A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

    open to eligible people ages 18-75

    Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. While levothyroxine is one of the most frequently prescribed medications in chronic kidney disease patients, little is known about its efficacy and safety in this population. This study will investigate 1) whether levothyroxine adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid hormone replacement improves quality of life and cardiovascular markers, without leading to wasting in dialysis patients.

    at UC Irvine

  • Activity Trackers for Improving BP

    open to eligible people ages 12-30

    The study aims to determine if use of physical activity trackers coupled with provider feedback will increase awareness of young adults of their physical fitness and improve blood pressure levels. The goal of this pilot study is feasibility, with a secondary goal of examining potential effect sizes for planning purposes for a larger randomized controlled trial.

    at UCSF

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

    open to eligible people ages 12-65

    This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.

    at UCLA

  • Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

    open to eligible people ages 18-99

    The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

    at UCLA

  • Decision Aid for Renal Therapy

    open to eligible people ages 70 years and up

    Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know all of their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, the investigators are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones. The DART study will be conducted at four sites in different areas of the country: Boston, Massachusetts; Portland, Maine; Chicago, Illinois; and San Diego, California. The study will enroll a total of 400 people with kidney disease at these four sites.

    at UCSD

  • EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

    open to eligible people ages 18 years and up

    The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease

    at UCLA

  • Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients

    open to eligible people ages 18 years and up

    Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.

    at UCLA UCSF

  • Kidney Awareness Registry and Education

    open to eligible people ages 18-75

    The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.

    at UCSF

  • Mild Hypothermia and Acute Kidney Injury in Liver Transplantation

    open to eligible people ages 18 years and up

    Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.

    at UCSF

  • Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

    open to eligible people ages up to 21 years

    Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

    at UCLA UCSD

  • Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood

    open to eligible people ages 13-30

    Hypertension is an increasingly common problem in children, especially among those who are obese or with diabetes and chronic kidney disease. This study is a pilot randomized controlled trial designed to test whether improved blood pressure control can be achieved with the use of remote home blood pressure monitoring in children with uncontrolled blood pressure.

    at UCSF

  • Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD

    open to eligible people ages 16 years and up

    The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a vulnerable and challenging period of time for patients and providers. Suboptimal control of blood pressure is known to be common in patients with the advanced stages of CKD, and may contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and mortality. This proposal is a pilot randomized controlled trial designed to test whether intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.

    at UCSF

  • The QUALITY Vets Project: Muscle Quality and Kidney Disease

    open to eligible people ages 18-84

    Currently there is no standard way to detect age-related skeletal muscle loss in patients with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways to measure muscle size and fat within the muscle.

    at UCSF

  • A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

    Sorry, not currently recruiting here

    The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

    at UCLA

  • A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring

    Sorry, accepting new patients by invitation only

    Evaluate the performance of the CorBand product when used to monitor patients.

    at UCSF

  • A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

    Sorry, not yet accepting patients

    The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

    at UCLA

  • A Trial of Doxycycline in Renal Disease

    Sorry, in progress, not accepting new patients

    The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID) will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease.

    at UCSF

  • ACEi ARB Withdrawal in CKD Patients

    Sorry, in progress, not accepting new patients

    The American Heart Association guidelines for high blood pressure (BP) currently recommend using angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) as first-line therapy for patients with chronic kidney disease (CKD) stage 3 or above. However, the prevalence of ACEi and ARB use in patients with CKD stage 4 or 5 is low, and current BP guidelines acknowledge the lack of solid evidence to support the benefit of using these agents in advanced CKD.This study seeks to conduct a pilot trial to determine the safety and feasibility of ACEi and/or ARB continuation (intervention) versus withdrawal (control) in patients with advanced CKD.

    at UCSF

  • An Exercise Study Testing Muscle Mitochondria (energy production) in Chronic Kidney Disease

    Sorry, not yet accepting patients

    Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of CKD with substantial adverse clinical consequences of disability, hospitalization, and death. Sarcopenia in this proposal is defined by impaired metabolism and physical function associated with decreased skeletal muscle mass or function. Skeletal muscle tissue relies on mitochondria to efficiently utilize oxygen to generate ATP. Impaired mitochondrial energetics is a central mechanism of sarcopenia in CKD. The investigators propose a series of studies designed to shed light on the pathophysiology of sarcopenia in persons with CKD not treated with dialysis. Investigators will conduct a randomized-controlled intervention trial of combined resistance training and aerobic exercise vs. health education to assess changes in skeletal muscle mitochondrial function, metabolism and physical function. Investigators hypothesize that exercise improves mitochondrial function and physical function in persons with CKD. If successful, these experiments will identify novel pathophysiologic mechanisms for CKD-associated sarcopenia. The proposed study will provide useful insight into benefits associated with exercise among patients with CKD and investigate mechanisms associated with improved metabolism, muscle function and physical function in population.

    at UC Davis

  • Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)

    Sorry, in progress, not accepting new patients

    The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.

    at UCLA

  • Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)

    Sorry, in progress, not accepting new patients

    The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.

    at UCLA

  • Angiotensin 2 for Hepatorenal Syndrome

    Sorry, not yet accepting patients

    Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure. The current treatment available in the United States is a combination of octreotide and midodrine, which are meant to decrease the release of those hormones and raise the blood pressure, respectively, which would increase blood flow to the kidneys. Angiotensin 2 (Ang2) is a new vasopressor drug that was approved by the FDA in December 2017 for patients with low blood pressure and has been shown to have similar effects to octreotide and midodrine. This study will investigate whether Ang2 reverses HRS among patients admitted to the intensive care unit (ICU) at Ronald Reagan Medical Center. Our study population will be patients with HRS who are already or will be admitted to the ICU. HRS will be defined by new internationally accepted guidelines published by the International Club of Ascites. All patients who are consented will undergo an Ang2 response trial, where low-dose Ang2 will be administered for 4 hours to see how the patients respond. This will help us characterize the nature of the patients' kidney failure for later analysis. Patients will then be randomized into the control group or the study group. Patients in the control group will receive octreotide (a subcutaneous injection) and midodrine (an oral drug). Patients in the study group will continue receiving intravenous infusion of Ang2. Patients in both groups will also receive albumin, a protein found commonly in human blood. Treatment will continue in both groups for four days, until complete reversal of HRS, dialysis, or death. Our primary outcome will be rate of reversal of HRS, defined as improvement in kidney function.

    at UCLA

  • APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

    Sorry, not currently recruiting here

    The APOLLO study is being done in an attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.

    at UCSF

  • Clinical Evaluation of PROMIS in CKD

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the clinical validity of a set of PROMIS pediatric person-reported outcome measures in patients with chronic kidney disease. The evaluation includes longitudinal assessments of how measures change in association with clinical changes.

    at UCLA

  • Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis

    Sorry, in progress, not accepting new patients

    The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

    at UC Irvine

  • Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates

    Sorry, in progress, not accepting new patients

    The study is designed as a randomized controlled trial. The investigators hypothesize that kidney transplant recipient candidates whose donors are offered reimbursement of lost wages (treatment arm) will have a higher probability of receiving a living donor kidney transplant than those randomized to no offer of lost wage reimbursement (control arm). The study expects to demonstrate incremental living donor kidney transplants by assisting individuals who wish to be living organ donors but would be otherwise unable to do so due to the obligatory forfeit of income during the evaluation, donation surgery, and post-operative recuperation periods.

    at UCLA

  • Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

    Sorry, in progress, not accepting new patients

    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.

    at UCLA

  • Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

    Sorry, in progress, not accepting new patients

    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.

    at UCLA UCSF

  • Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

    Sorry, in progress, not accepting new patients

    A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with DD-CKD

    at UCLA

  • Endothelial Function and Arterio-Venous Fistula Maturation

    Sorry, in progress, not accepting new patients

    An arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. A primary aim of this study is to see if endothelial function (the biochemical events initiated by cells lining the arteries) is associated with successful maturation. Other aims include determining if pro-inflammatory markers in the blood or evidence of gene expression are associated with successful maturation.

    at UCSF

  • Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

    Sorry, not yet accepting patients

    The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.

    at UC Irvine

  • Explore Transplant @Home Within Kaiser Permanente Southern California

    Sorry, in progress, not accepting new patients

    Today, there are 25 million Americans with chronic kidney disease (CKD) and 660,000 patients in full kidney failure, the final CKD stage, known as end stage renal disease (ESRD). Over half of ESRD patients are Black, Hispanic, or Asian. ESRD patients must either receive regular dialysis treatments, by which waste is filtered from the blood by a machine, or a kidney transplant from a deceased or living donor. Five-year survival on dialysis is only 40%, compared to 74% with a deceased donor kidney transplant (DDKT) and 87% with a living donor kidney transplant (LDKT). Despite the known health benefits of DDKT and LDKT, 70% of ESRD patients remain on dialysis, especially ethnic/racial minorities. An American Society of Transplantation (AST) Consensus Conference recently recommended that patients in all CKD stages should have the opportunity to learn about and decide which treatment option is right for them, particularly about LDKT. However, early education about LDKT and DDKT is inconsistent and often poor, with early stage CKD patients and ethnic/racial minorities even less likely to receive it. Through previous HRSA grants, Dr. Waterman designed the Explore Transplant@Home (ET@Home) video-guided education program, and found that it significantly increased LDKT knowledge and informed decision-making for Black and White dialysis patients in Missouri when delivered by mail and supported through bimonthly postcards and texting. Now based at the University of California, Los Angeles (UCLA), she has partnered with Kaiser Permanente Southern California (KPSC), an integrated learning healthcare system providing insurance coverage and comprehensive care to 65,000 patients in CKD Stages 3, 4 and 5 (ESRD) (24% Hispanic, 52% White, 15% Black, and 9% Asian; 10% Spanish-speaking).

    at UCLA

  • Gout: Allopurinol vs. Febuxostat

    Sorry, in progress, not accepting new patients

    This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attacks. These therapies have never been compared at appropriate doses. Further, they will be studied in patients with kidney disease for the first time.

    at UCSD UCSF

  • Phosphate Microvascular Study

    Sorry, not yet accepting patients

    Elevated phosphate concentrations in the blood have been associated with multiple negative health outcomes in patients with chronic kidney disease as well as in the general population. These negative outcomes include an increased risk of vascular complications like heart attack and stroke. While complications like heart attack and stroke reflect obstructive disease in large blood vessels, recent evidence suggests that elevated phosphate concentrations may first lead to disease in small blood vessels. This single site clinical trial will randomize 20 veterans with end stage renal disease on hemodialysis to either a phosphate binder or placebo and evaluated for changes in their microvascular function using laser-Doppler flowmtery and nail-fold capillaroscopy.

    at UCSD

  • Smarter Care Virginia

    Sorry, in progress, not accepting new patients

    Low-value care is defined as patient care that provides no net benefit to patients in specific clinical scenarios, and it can cause patient harm. Prior research has documented high-rates of low-value care in Virginia, and this work has helped to inspire a Virginia government-sponsored quality improvement initiative to reduce low-value care. Funded by a $2.2 million Arnold Ventures grant, six large health systems in Virginia volunteered to partner with the Virginia Center for Health Innovation (VCHI) to reduce use of seven low-value health services (three preoperative testing measures, two cardiac screening measures, one diagnostic eye imaging measure, and one peripherally inserted central catheter [PICC] measure). These health systems include nearly 7,000 clinicians practicing across more than 1,000 sites. VCHI is implementing a step-wedge cluster-randomized physician peer-comparison feedback quality improvement intervention to reduce the use of these seven low-value services. VCHI will provide education, quality improvement training, and financial resources to each site, and VCHI will use the Milliman MedInsight Health Waste Calculator to create the peer comparison reports using the Virginia all payer claims database (APCD). Of note, the primary purpose of the initiative is to improve quality of care for Virginia residents and this initiative is not being done for research purposes, and step-wedge randomization is done to both ease logistical workload on VCHI and clarify impact of intervention (IRB exempt). Nevertheless, University of California, Los Angeles (UCLA) team plans to rigorously study and publish the impact of this intervention across the state of Virginia, which is why the UCLA team is preregistering the initiative. The UCLA team will use the Virginia APCD to evaluate the impact of the intervention. Because the APCD has a 1 year time-lag of data collection, the initial results of the impact of the intervention will not be available until August 2020 at the earliest.

    at UCLA

  • Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score

    Sorry, not currently recruiting here

    The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).

    at UCLA

  • The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE

    Sorry, in progress, not accepting new patients

    The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients with Chronic Kidney Disease (CKD) stages 3-4.

    at UCSD

  • The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury

    Sorry, in progress, not accepting new patients

    The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the investigators will draw blood and urine for novel and standard biomarkers. The investigators are attempting to determine if these biomarkers can forecast the course of AKI (need for dialysis, death and renal recovery). The investigators seek to determine how well physicians caring for those with AKI can predict the clinical course compared to these novel biomarkers of AKI and if there is an association between clinical course and 3 year patient outcomes.

    at UCSF

  • VIRTUUS Children's Study

    Sorry, not currently recruiting here

    The objective of the VIRTUUS Children's Study is to adapt identified and validated adult noninvasive diagnostic and prognostic biomarkers for the characterization of allograft status in pediatric recipients of kidney allografts.

    at UCLA

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