Material Balance Study of TQ-B3525
Chronic Kidney DiseasesMagnetic Resonance ImagingA clinical study to investigate the absorption, metabolism and excretion of [14C] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of [14C] TQ-B3525, obtain the data of human radioactive excretion rate and main drainage routes, investigate the distribution in whole blood and plasma, the distribution in plasma and the pharmacokinetics of total radioactivity in plasma, and identify the main metabolites, To determine the main biotransformation pathway and obtain the pharmacokinetic parameters of TQ-B3525 and its metabolites in plasma.
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Chronic Kidney DiseasesEnd Stage Renal Disease8 moreThis is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new AVF in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus
CBDTransplant Complication2 moreThe information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.
Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a...
Diabetes Mellitus Type 2 With ProteinuriaDiabetes Mellitus12 moreThe goal of this clinical trial is to determine the feasibility of remote clinical trial conduct in patients with type 2 diabetes and elevated albuminuria. The main questions it aims to answer are: What is the feasibility (and advantages) of remote clinical trial conduct with multiple medications in patients with type 2 diabetes and elevated albuminuria? What is the individual response to the SGLT2 inhibitor empagliflozin in urine albumin-creatinine ratio? What is the individual response to the SGLT2 inhibitor empagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose? Can suboptimal treatment responses to empagliflozin be overcome by the addition or substitution with finerenone? Participants will collect all study data in the comfort of their own environments First-morning void urine samples Capillary blood samples Blood pressure Body weight Participants will be assigned to a 3-week treatment period with empagliflozin 10 mg/day. Based on the albuminuria response after 2 weeks, participants will be allocated to one of three treatment regimens after the 3-week treatment period with empagliflozin: Continue empagliflozin for 4 more weeks (good response). Continue empagliflozin for 4 more weeks and add finerenone 10 or 20 mg will be added for 4 weeks (moderate response). Stop empagliflozin and start finerenone 10 or 20 mg for 4 weeks (no response)
Demethylating Agent Azacitidine on Prevention of Acute Kidney Injury-chronic Kidney Disease Continuum...
Acute Kidney DiseaseAcute kidney injury (AKI) is increasing worldwide in recent years and is a major risk factor of chronic kidney disease (CKD). AKI, acute kidney disease (AKD) and CKD form a continuum whereby initial kidney injury leads to ongoing renal injury and eventually end-stage renal disease if no effective treatment is applied. Nevertheless, there are no useful pharmacotherapies approved clinically for the treatment of AKI and subsequent CKD. Previous studies of the investigators have confirmed that pericytes are the primary cell source of scar-producing myofibroblasts. Furthermore, the investigators had demonstrated that significant epigenetic modification in transcriptome analysis of pericytes develops in different stage of AKI-CKD continuum. These epigenetic memory made pericytes obtain proliferative and pro-fibrotic phenotypes in activated status and persist in inactivated status. Demethylation by azacitidine prevented AKI-CKD transition, and attenuated fibrogenesis induced by a second adenine-AKI. Azacitidine has been approved in the United States Food and Drug Administration and European Union for treatment of adult acute myeloid leukemia (AML), particularly recommended front-line treatment for older patients with acute myeloid leukemia who are not candidates for intensive treatment regimens. Dosage of azacitidine in clinical trial is calculated according to previous study and is lower than chemotherapeutic dose. Low dose azacitidine has demethylation effect and less cytotoxicity. CSA-AKI is the second commonest cause of AKI in ICU. The investigators plan to initiate a double-blind randomized controlled trial (RCT) to recruit CSA-AKI patients. The patients will be divided as azacitidine group and placebo group. Patients in azacitidine group will receive three doses of low dose azacitidine in one week when AKI is diagnosed. After that, the investigators will follow up their renal function and urine protein every three month. Primary composite outcomes include a decline of at least 50% in the estimated GFR, an increase of urine protein-creatinine ratio (UPCR) over 1000 mg/g, and the development of end stage renal disease (ESRD). Secondary outcome is overall mortality.
Outcomes of Neonatal Acute Kidney Injury In Premature Infants
Acute Kidney InjuryChronic Kidney DiseaseThe objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to a comprehensive clinical database.
Early Screening and Diagnosis of CKD
Kidney; Disease (Functional)Chronic Kidney DiseaseChronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in adults in China was 10.8%. Albuminuria measurement and estimating glomerular filtration rate (GFR) are the primary means of screening for CKD in epidemiological investigations. However, there are many important problems to be solved, whether albuminuria test or GFR evaluation. The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months, with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein excretion rate (PER) and 24-hour albumin albumin excretion rate (AER) to compare the effects of different times of screening for CKD and observe the daily physiological variation of ACR, PCR, AER and PER, derive ACR and PCR reference value on the basis of different genders, in order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment of GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP) based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid (DTPA) renal clearance method. Then to develop GFR estimation equation based on the combination of serum creatinine, cystatin C, β2 -microglobulin and BTP applicable in China.
IVUS Guided PCI for CKD to Reduce CI-AKI
Coronary Artery DiseaseChronic Kidney DiseasesPatients with Chronic kidney disease are most vulnerable to contrast induced nephropathy after Percutaneous coronary intervention, intravascular ultrasound guidance can be used to safely guide the procedure to reduce the contrast usage, this randomized trial is design to test the hypothesis that IVUS based ultra-low contrast PCI is feasible and can reduce the contrast induced nephropathy.
Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced...
Dialysis; ComplicationsHeparin-induced Thrombocytopenia1 moreThis research is based on the hypothesis that the Hydrolink®-NV dialysis membrane could allow the realization of quality dialysis with a significant reduction in the doses of Orgaran®, or even a total cessation of the anticoagulant, in patients with chronic renal failure. with heparin-induced thrombocytopenia. Thus, this study aims to show that the use of this dialysis membrane without prior anticoagulation does not increase the risk of coagulation of the circuit and allows the realization of quality dialysis sessions.
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients With Chronic Kidney...
PruritusThis is a multi-center, randomized, double-blind, placebo-controlled study. About 310 maintenance hemodialysis patients with moderate or above chronic kidney disease-associated pruritus are planned to be enrolled. They will randomized into the treatment group (HSK21542, 0.3 μg/kg) and the control group (placebo) at a 1:1 ratio.