Berinert (C1INH) vs Placebo for DGF/IRI
End Stage Renal DiseaseChronic Kidney DiseasesThis is a Phase I/II double-blind, randomized, placebo-controlled study assessing safety and limited efficacy of intraoperative C1INH (500U/kidney) vs. Placebo administered into the graft renal artery 1-2 hours prior to implantation in adult subjects receiving a deceased donor kidney allograft considered high-risk for development of DGF (KDPI>80). Once eligible patients are identified, consented, and have an acceptable kidney transplant offer, they will be randomized by the Cedars-Sinai Research Pharmacy to receive study drug vs. placebo. Drug and placebo will be prepared by the Cedars-Sinai Research Pharmacy and conveyed to the operating room in a blinded manner. The drug will be administered by the transplant surgeon in the OR in a blinded manner.
RAYALDEE Non Interventional Study (NIS) on Effectiveness in ND-CKD SHPT Patients
Chronic Kidney DiseaseThe purpose of this study is to generate data on the effectiveness of Rayaldee® to gradually increase 25-hydroxyvitamin D (25D) safely and to a high enough magnitude to reliably reduce elevated parathyroid hormone in patients with non-dialysis chronic kidney disease. Rayaldee®, a prolonged-release calcifediol (PRC) formulation, is an orally administered prohormone of active vitamin D (1,25-dihydroxyvitamin D [1,25D]) designed to increase serum total 25-hydroxyvitamin D (25D) safely and to a high enough magnitude to reliably reduce elevated parathyroid hormone (PTH) in patients with non-dialysis chronic kidney disease (ND-CKD). Clinical studies show that PRC is an effective, well tolerated treatment for secondary hyperparathyroidism (SHPT) in ND-CKD patients with vitamin D insufficiency or deficiency. PRC gradually raises serum 25D levels, resulting in physiologically regulated increases in serum 1,25D and sustained and progressive reductions in PTH levels, while avoiding clinically meaningful increases in serum phosphate and calcium. To date, experience with the use of Rayaldee® results exclusively from patients from the United States and mainly from patients who have participated in clinical trials. It is therefore of major interest to observe the value of Rayaldee® in daily use outside of controlled trial settings with a larger sample size and in Europe.
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Chronic Kidney DiseasesThis project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.
Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney...
Heart FailureChronic Kidney Diseases1 moreThe purpose of this study is to conduct a a cohort study to evaluate the efficacy and safety of the efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease.
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases...
Essential HypertensionLiver Cancer9 moreThe human gut microbiome has been associated with many health factors but variability between studies limits the exploration of effects between them. This study aims to systematically characterize the gut microbiota of various critical chronic diseases, compare the similarities and differences of the microbiome signatures linked to different regions and diseases, and further investigate their impacts on microbiota-based diagnostic models.
Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic...
Heart FailureType 2 Diabetes1 moreThis study will be a prospective randomized implementation trial for patients hospitalized with heart failure, chronic kidney disease, and/or type 2 diabetes mellitus within Duke University Medical Center. The primary hypothesis is that a virtual quality improvement-based consult intervention will improve the rate of in-hospital evidence-based cardio-renal-metabolic medication use, particularly SGLT2 inhibitor therapy. Approximately 200 patients meeting eligibility criteria will be included in the study. Patients will be assigned into study groups, as defined by randomization of their treating clinician team to receiving the virtual consult versus not.
A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic...
Type 2 Diabetes MellitusChronic Kidney DiseasesThe purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Impact of Lifestyle Modification on the Development of Dementia, Chronic Kidney Disease, Diabetes,...
DementiaDiabetes Mellitus4 moreThis is a community-based cluster randomized control trial aimed to investigate the impact of lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive pulmonary disease and cardiovascular disease in an intermediate risk population in mixed urban-rural areas of Ubon Ratchathani.
The ILERVAS Project: Assessing the Prevalence of Subclinical Vascular Disease and Hidden Kidney...
AtherosclerosisChronic Kidney Diseases3 moreBACKGROUND AND OBJECTIVES: Cardiovascular disease is the leading cause of death despite huge primary and secondary prevention policies with a strong economic burden. The primary objectives of the ILERVAS project are: (i) to identify unknown factors involved in the presence of atherosclerosis, metabolic syndrome, pre-diabetes and hidden kidney disease in a low/moderate cardiovascular risk population; (ii) to identify unknown factors involved in the progression of atherosclerosis, metabolic syndrome, pre-diabetes and hidden kidney disease in a low/moderate cardiovascular risk population; (iii) to Assess of the impact of arterial ultrasound on cardiovascular events and mortality in a low/moderate cardiovascular risk population. METHODS: Randomized intervention study. From 2015 to 2018, 16,660 participants (8,330 in the intervention group (Mobile Unit Follow-up Group) and 8,330 in the no intervention group (Electronic Medical History Follow-up Group )) aged between 45 and 70 years without a previous history of cardiovascular disease and with at least one cardiovascular risk factor will be randomly selected across the province of Lleida, Spain.
Early Detection of Progressive Kidney Disease in Preterm Infants
Chronic Kidney DiseasesCardiovascular DiseasesInfants born preterm and of low birth weight are known to be at increased risk for early onset of cardiovascular and renal disease in adult life. This has been related to low nephron mass due to inadequate or early termination of glomerulogenesis in utero and during the perinatal period. Risks for subsequent development of hypertension and kidney disease include proteinuria, excessive weight gain during early life with insulin resistance and supplemental high calorie feedings. The long-term goal is for early diagnosis of those infants who are at risk for future development of hypertension and kidney disease so that the investigators might intervene to potentially avert progression to adult disease. The objective of this clinical trial is to acquire data on the natural history of neonatal kidney function and size in infants born preterm during the first 2 years of life. This will be done through the use of standard serum and urine markers as well as non-invasive ultrasound technology. The central hypothesis of this clinical trial is that a subgroup of patients born preterm and of low birth weight will demonstrate early markers of kidney injury including elevated serum cystatin C, proteinuria and low kidney size. This hypothesis has been formulated on the basis of preliminary data from our group studying this question retrospectively in older children born prematurely who have developed overt kidney disease. The rationale for the proposed research is to develop early serum and demographic markers of pre-clinical kidney disease so that early intervention can occur. The proposed clinical trial is innovative because it will investigate the risk factors for kidney dysfunction at a pre-clinical stage with the idea of gaining more knowledge regarding therapeutic interventions. In addition, the study will assess serum cystatin C as a surrogate test for glomerular filtration rate which could indicate worsening kidney function at an earlier stage than serum creatinine. The proposed research is significant because it is expected to identify at-risk patients for future renal impairment and to prospectively monitor the persistence of proteinuria and its effect on kidney function in the short term.