Clinical trials in end-stage renal disease—priorities and challenges

2019 ◽  
Vol 34 (7) ◽  
pp. 1084-1089 ◽  
Author(s):  
Csaba P Kovesdy
Keyword(s):  
Clinical Trials ◽  
Renal Disease ◽  
End Stage Renal Disease ◽  
Clinical Trial Design ◽  
Therapeutic Interventions ◽  
High Morbidity ◽  
Design Elements ◽  
Pragmatic Clinical Trials ◽  
Stage Renal Disease ◽  
End Stage

AbstractPatients with end-stage renal disease (ESRD) experience extremely high morbidity and mortality and there are virtually no therapeutic interventions besides dialysis treatment that are proven in properly designed randomized controlled trials (RCTs) to improve patients’ outcomes. Historically, the number of RCTs performed in the ESRD population has been very low compared with other medical subspecialties, and several of the few large RCTs have yielded inconclusive or negative results, dampening enthusiasm for future investment in similar trials. Recent initiatives promoting a focus on patient-centered outcomes and more active patient and caregiver involvement in the planning and conduct of clinical trials may result in more clinically relevant RCTs and broader participation from patients representing the diversity of the ESRD population. The adoption of novel clinical trial design elements characteristic of pragmatic clinical trials and platform trials could help improve both the internal and external validity of RCTs in ESRD, ultimately resulting in the adoption of therapeutic interventions that can be rapidly translated to clinical practice.

scholarly journals Novel Haplotype Indicator for End-Stage Renal Disease Progression among Saudi Patients

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Cyril Cyrus ◽  
Shahanas Chathoth ◽  
Chittibabu Vatte ◽  
Nafie Alrubaish ◽  
Othman Almuhanna ◽  
...  
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Haplotype Analysis ◽  
Taqman Assay ◽  
Rapid Progression ◽  
High Morbidity ◽  
Glomerular Diseases ◽  
Increased Risk ◽  
Stage Renal Disease ◽  
End Stage

Background. End-stage renal disease (ESRD) is the result of hypertensive nephrosclerosis and chronic glomerular diseases and is associated with high morbidity and mortality. There are strong heritable components in the manifestation of the disease with a genetic predisposition to renal disorders, including focal segmental glomerulosclerosis and arterionephrosclerosis. Recent studies in genetics have examined modifiable risk factors that contribute to renal disease, and this has provided a deep insight into progressive kidney disease. Single-nucleotide polymorphisms at the proximity of SHROOM3, CST3, SLC7A9, and MYH9 genes have been associated with an increased risk of developing CKD and ESRD. Methods. A total of 160 CKD patients and 189 control subjects of Saudi origin participated in the study. Eight polymorphisms (SHROOM3-rs9992101, rs17319721; SLC7A9-rs4805834; MYH9-rs4821480, rs4821481, rs2032487, rs3752462; CST3-rs13038305) were genotyped using TaqMan assay, and the haplotype analysis was done using the HaploView 4.2 software. Results. Haplotype analysis revealed a novel haplotype “E6”-GTTT to be associated significantly with an increased risk for ESRD (p=0.0001) and CKD (p=0.03). Conclusion. CKD is often silent until symptomatic uremia during the advanced stages of the disease. The newly identified haplotype will help recognize patients at risk for a rapid progression of CKD to ESRD. Accurate detection and mapping of the genetic variants facilitates improved risk stratification and development of improved and targeted therapeutic management for CKD.

scholarly journals Asymptomatic cardiac manifestations in CKD

2018 ◽  
Vol 6 (3) ◽  
pp. 822
Author(s):  
Adarsh L. S. ◽  
Sravanthi Reddy ◽  
Manjunath S. Shetty
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Pressure Overload ◽  
Primary Objective ◽  
Therapeutic Interventions ◽  
Health Concern ◽  
Cross Sectional ◽  
Stage Renal Disease ◽  
End Stage ◽  
Cardiac Manifestations

Background: Chronic kidney disease is recognised as health concern globally with more than 40 percent of morbididty and mortality. CKD is one of the independent risk factor for cardiovascular diseases and its unfavourable health outcomes. The risk factors like smoking, hypertension, dyslipidemia and diabetes which are highly prevalent in CKD. The therapeutic interventions in CKD patients to reduce CVD events does not hold a desired effect and has bad prognosis in end stage renal disease. The initial evidence indicating a relationship between CKD and CVD is more apparent in patient with dialysis. The aim of the study was to evaluate the asymptomatic cardiac manifestations in 2-4 stages of CKD through non-invasive methods like ECG and Echocardiography.Methods: It is a cross sectional study investigated on 250 CKD patients receiving care in JSS hospital, Mysore. For the primary objective, correlational analysis were performed to evaluate the association of renalfunctional parameters like serum creatinine, urine albumin, eGFR with cardiac parameters through ECG and Echocardiographic changes.Results: ECG revealed LVH with pressure overload pattern in 36%. 25% patients had ST-T changes. Echocardiography revealed LVH and diastolic dysfunction as abnormalities. LVH has significant p value.Conclusions: CVD is a leading cause of morbidity and mortality in patients of CKD who succumb to Cardio vascular deaths before reaching the end stage renal disease. Thus, focus of patient care in early CKD stages should be directed to prevention of cardiovascular complications through early ECG and Echocardiography.

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