Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment...
Chronic Kidney DiseaseThis is a double-blind, randomized, active-control study with 2-study arms-darbepoetin alfa biosimilar and Aranesp, noninferiority trial design in dialysis patients. Dialysis patients will be randomized into 1:1 ratio to receive either Darbepoetin alfa or Aranesp 0.75 µg/kg by subcutaneous injection every other week for 24 weeks. Pharmacokinetic/pharmacodynamic parameters for evaluation are assessed as per study endpoints at defined time points on all patients. During the treatment, dose adjustments will be made as necessary to achieve a hemoglobin response, defined as maintaining Hb in target range 10 - 12 g/dL.
Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects
Chronic Kidney DiseaseThis is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.
A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the...
AnemiaChronic Kidney Disease Requiring Chronic DialysisThis is a double-blind, two-arm, randomized, multicenter to compare the efficacy and safety of NNG-DEPO and Aranesp in CKD on dialysis patients. Patients aged 18 to 65 years (inclusive), diagnosed with anemia due to CKD in dialysis, who meet all inclusion criteria, requiring treatment with Darbepoetin alfa. The study subjects (patients) will be randomized into a 1:1 ratio to NNG-DEPO and Aranesp treatment arms respectively. Patients will receive either NNG-DEPO or Aranesp 0.75 µg/kg by subcutaneous injection every other week for 24 weeks. During the treatment, dose adjustments will be made as necessary to achieve a hemoglobin response, defined as maintaining Hb in the target range of 10 - 12 g/dL.
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Kidney DiseasesMetabolic Acidosis3 moreThe goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control. Our hypothesize is that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.
A Study of Renal Microvessel Imaging for Chronic Kidney Disease
HealthyChronic Kidney DiseasesThe purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Definity is an ultrasound contrast agent currently approved by the FDA for use on the heart, liver, and urinary tract. This study will look at its effectiveness on the kidney.
Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease
Chronic Kidney DiseasesCognitive DeclineThe proposed research is clinical study evaluating the therapeutic benefits of curcumin on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that curcumin will improve endothelial function and reduce large artery stiffness by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in patients with CKD.
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen
Renal FailureRenal Insufficiency3 moreThe purpose of this study is to demonstrate non-inferiority of an advagraf based immunosuppressive regimen with slower dose tapering and lower starting dose of Advagraf compared with a standard Advagraf-based immunosuppressive regimen in de novo renal transplantation. Non inferiority will be assessed by a combined study endpoint consisting of the development of biopsy-proven rejection of BANFF class Ia or higher and/or graft loss and/or patient death within the first six months after renal transplantation.
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
Anaemia Associated With Chronic Kidney DiseaseThis is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
Metabolic AcidosisChronic Kidney Disease1 moreThis is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.
Evaluating the Implementation of Evidence-Based Kidney Nutrition Practice Guidelines: The AUGmeNt...
Chronic Kidney DiseasesEvidence-Based Nutrition Practice Guidelines (EBNPGs) inform registered dietitian nutritionist (RDN) care for patients with chronic kidney disease grade 5 treated by dialysis (CKD G5D); however, there has been little evaluation of best practices for implementing EBNPGs. In this effectiveness-implementation hybrid study with a quasi-experimental design, United States RDNs in hemodialysis clinics will document initial and follow-up nutrition care for patients with CKD G5D using the Academy of Nutrition and Dietetics Health Informatics Infrastructure (ANDHII) before and after being randomly assigned to a training model: 1) EBNPG knowledge training, or 2) EBNPG knowledge training plus an implementation toolkit. Aims of the study include examining congruence of RDN documentation of nutrition care with the EBNPG; describing common RDN-reported EBNPG acceptability, adoption and adaptation issues; and determining the feasibility of estimating the impact of RDN care on nutrition-related patient outcomes. The AUGmeNt study can inform effective development and implementation of future EBNPGs.