Immunogenicity of HPV Vaccine in Transplant Recipients.
Chronic Kidney DiseasesKidney TransplantTo measure levels of HPV antibodies in pre-renal organ transplant and renal transplant recipients who have gotten the HPV9 vaccine and compare to control antibody levels.
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.
Urinary Biomarkers in Paediatric Kidney Transplantation (pKTx)
Renal TransplantationChronic Kidney Insufficiency1 moreThis study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may be observed after event-specific injury, (3) differences between paediatric renal transplant patients with AR and other causes of AKI can be detected, and (4) stratification of renal transplant patients to different histological types of AR is possible.
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.
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.
Role of Coenzyme Q10 in Chronic Kidney Disease
Chronic Kidney DiseasesThis randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium < 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups. Group 1: Control group Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control. Group 2: Coenzyme Q10 Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day. The dose of ramipril may be modified according to blood pressure control. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult...
Chronic Kidney Failure in Children and Young AdultsRecent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.
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.
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.