Pharmacokinetics, safety, and tolerability of edoxaban in end-stage renal disease subjects undergoing haemodialysis

2015 ◽  
Vol 113 (04) ◽  
pp. 719-727 ◽  
Author(s):  
Thomas Marbury ◽  
Nobuko Matsushima ◽  
Shuquan Chen ◽  
Prachi K. Wickremasingha ◽  
Ling He ◽  
...  
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Phase 1 ◽  
Factor Xa ◽  
Chronic Haemodialysis ◽  
Open Label ◽  
Open Label Phase ◽  
Stage Renal Disease ◽  
A Minor ◽  
End Stage

SummaryEdoxaban is an oral, direct, once-daily, factor Xa inhibitor developed for stroke prevention in patients with atrial fibrillation and for the treatment and secondary prevention of recurrent thromboembolism in patients with acute symptomatic venous thromboembolism. Among elderly patients who require anticoagulation therapies, some may have end-stage renal disease (ESRD). This open-label, phase 1, randomised, two-way crossover study was conducted to evaluate the pharmacokinetics of edoxaban in 10 subjects on haemodialysis. Eligible subjects with ESRD on chronic haemodialysis received a single, oraldose of edoxaban 15 mg 2 hours (h) prior to (on-dialysis) or in between (off-dialysis) haemodialysis sessions. Haemodialysis resulted in a minor decrease in mean total exposure (AUC0-∞; 676.2 ng⋅h/ml) as compared with that observed in subjects off-dialysis (691.7 ng⋅h/ml). Mean maximum observed plasma concentration (Cmax) values were comparable between on-dialysis and off-dialysis treatments (53.3 vs 56.3 ng/ml, respectively). Mean apparent total body clearance (CL/F) values were 24.1 and 22.5 l/h during the on-dialysis and off-dialysis treatment periods, respectively. Dialyser clearance was 5.7 l/h and haemodialysis clearance was 6.1 l/h. Haemodialysis clearance was only 6.1 l/h, suggesting that it only accounts for one-fourth of the total clearance in these subjects. A single, oral dose of 15 mg of edoxaban was well tolerated by subjects with ESRD. In conclusion, based on these single-dose PK data, a supplementary dose of edoxaban may not be required following a haemodialysis session. Importantly, haemodialysis is not an effective mechanism for removal of edoxaban from the blood.

scholarly journals Electrocardiogram changes in patients with end stage renal disease on chronic haemodialysis

2019 ◽  
Vol 7 (11) ◽  
pp. 4020
Author(s):  
Kareem Mohsin Yousif ◽  
Hamid Obaid Khadhim Al Jaaed
Keyword(s):  
Renal Disease ◽  
Social History ◽  
End Stage Renal Disease ◽  
Cross Sectional Study ◽  
Premature Ventricular Complex ◽  
Chronic Haemodialysis ◽  
Ecg Changes ◽  
Cross Sectional ◽  
Stage Renal Disease ◽  
End Stage

Background: End stage renal disease (ESRD) is irreversible loss of renal function which is physiologically defined by a GFR of less than 15 ml / minute. ESRD is associated with a higher incidence of coronary artery disease and serious arrhythmia especially ventricular arrhythmia. The goal of study is to determine whether ESRD and haemodialysis (HD)are associated with occurrence of significant electrocardiogram (ECG) changes or not.Methods: This is a cross-sectional study design which involved 22 patients with ESRD on regular HD in Al Sadre teaching hospital / Al Najaf. Both sexes was included in this study. All patients underwent full medical history and examination which included the following aspects: Age, Sex, Occupation, BP, HR, RBS, B.urea, S.creatinine , Serum electrolyte (Na+, K+, Cl-, Ca++), Lipid profile (Cholesterol , Triglyceride, HDL, LDL), Duration of CRF, Duration of dialysis, Social history including (smoking, alcohol) and Drug used by the patient. Resting EGC and Hotler ECG.Results: Eighteen patients exhibited emergence of simple ectopic activity premature atrial complex (PAC) and premature ventricular complex (PVC) events and four patients exhibited (ST,T changes). Potentially lethal arrhythmias and other serious ECG changes are not detected in our patient’s sample.Conclusion: In this study, neither ESRD nor haemodialysis were associated with development of serious ECG changes or emergence of significant arrhythmia.

A phase Ib, open-label, single arm study to assess the safety, pharmacokinetics, and impact on humoral sensitization of SANGUINATE infusion in patients with end-stage renal disease

2017 ◽  
Vol 32 (1) ◽  
pp. e13155 ◽  
Author(s):  
Bassam G. Abu Jawdeh ◽  
Ervin Steve Woodle ◽  
Abbie D. Leino ◽  
Paul Brailey ◽  
Simon Tremblay ◽  
...  
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Open Label ◽  
Phase Ib ◽  
Stage Renal Disease ◽  
End Stage

scholarly journals Relationship between Zink and Anaemica in Chronic Haemodialysis Patients

1970 ◽  
Vol 16 (1) ◽  
pp. 12-14 ◽  
Author(s):  
Nasima Akhtar ◽  
Raghib Ahsan ◽  
Md Abdul Wakil ◽  
CGM Mostafa ◽  
Sakhi Chowdhury ◽  
...  
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Zinc Level ◽  
Chronic Haemodialysis ◽  
Plasma Zinc ◽  
Stage Renal Disease ◽  
End Stage ◽  
Esrd Patients ◽  
Haemoglobin Synthesis ◽  
Plasma Zinc Level

End stage renal disease (ESRD) patients receiving haemodialysis (HD) are frequently associatedwith anaemia. Zinc, being an important nutrient for haemoglobin synthesis, was studied for it'seffect, if any, on renal disease associated anaemia among patients in the HD unit of BSMMU(formerly IPGMR), Dhaka. Surprisingly, a tow plasma zinc level and a high corpuscular (RBC)zinc level was observed. All of our subjects were found anaemic. A significant correlation wasobserved between plasma zinc level on one hand and haemoglobin level as well as RBC countson the other hand. There are several suggestions for this low plasma and high corpuscular zinclevel. However, this altered zinc level in plasma and red blood corpuscles might interfere withhaemoglobin synthesis and might be one of the factors for renal disease associated anaemia.doi: 10.3329/taj.v16i1.3895TAJ June 2003; Vol.16(1): 12-14

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