A multi-dose pharmacokinetic study of dalteparin in haemodialysis patients

2006 ◽  
Vol 96 (12) ◽  
pp. 750-755 ◽  
Author(s):  
Stephen Byrne ◽  
Lynda Szczech ◽  
Thomas Ortel ◽  
Stephanie Perry ◽  
Susan O’Shea
Keyword(s):  
Body Weight ◽  
Area Under The Curve ◽  
Factor Xa ◽  
Renal Elimination ◽  
Low Molecular Weight Heparins ◽  
Lower Body Weight ◽  
Multiple Blood ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage

SummaryLow-molecular-weight heparins undergo renal elimination, and therefore the proper dosing in hemodialysis (HD) patients is unclear. It was the objective of this study to evaluate the pharmacokinetic (PK) parameters of dalteparin in patients receiving chronic HD for end-stage renal disease. We performeda multidose PK study with prophylactic doses of dalteparin in twelve HD patients. Dalteparin 5,000 IU was administered subcutaneously daily for four consecutive days, with HD performed on day2 and day 4. Anti-factor Xa activity was determined daily and at multiple blood samples after the 3rd and 4th dose. Eleven of 12 patients completed the study. The mean (range) PK parameters determined after the 4th dose were as follows: i) maximum concentration (Cmax) was 0.31 IU/ml (0.06 to 0.55 IU/ml); ii) time to Cmax was 3.55 hours (2.59 to 4.96 hr); iii) area under the curve was 3.24 IU*hr/ml (0.64 to 6.44 IU*hr/ml); iv) half-life was 3.82 hr (2.03 to 9.63 hr); and v) trough anti-factor Xa activity 0.04 IU/ml (0.02 to 0.08 IU/ml). No major bleeding was observed. In general, patients with lower body weight exhibited a higher Cmax. From this pilot PK study, we have determined initial PK parameters for dalteparin in HD patients. Although a standard prophylactic dose was used, we found that in this patient population differences in body weight influenced the Cmax. Future studies to evaluate the PK parameters of dalteparin in patients receiving chronic HD may have to use weight-based dosing and will need to be performed over a longer period of time.

scholarly journals Addition of eGFR and Age Improves the Prognostic Absolute Renal Risk-Model in 1,134 Norwegian Patients with IgA Nephropathy

2015 ◽  
Vol 41 (3) ◽  
pp. 210-219 ◽  
Author(s):  
Thomas Knoop ◽  
Ann Merethe Vågane ◽  
Bjørn Egil Vikse ◽  
Einar Svarstad ◽  
Bergrún Tinna Magnúsdóttir ◽  
...  
Keyword(s):  
Iga Nephropathy ◽  
Prognostic Model ◽  
Risk Model ◽  
Area Under The Curve ◽  
Predicting Outcome ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage ◽  
French Cohort

Background: Predicting outcome in individual patients with IgA nephropathy (IgAN) is difficult but important. For this purpose, the absolute renal risk (ARR) model has been developed in a French cohort to calculate the risk of end-stage renal disease (ESRD) and death. ARR (0-3) is scored in individual IgAN patients based on the presence of proteinuria ≥1 g/24 h, hypertension, and severe histopathological lesions (1 point per risk factor). We have validated the ARR model in a Norwegian cohort of IgAN patients and tested whether adding data on initial estimated glomerular filtration rate (eGFR) and age improved prediction. Methods: IgAN patients diagnosed between 1988 and 2012 were identified in the Norwegian Kidney Biopsy Registry, and endpoints were identified by record linkage with the Norwegian Renal Registry (ESRD) and the Population Registry (deaths). Results: We identified 1,134 IgAN patients. The mean duration of follow-up was 10.2 years (range 0.0 to 25.7 years). Two hundred and fifty one patients developed ESRD and there were 69 pre-ESRD deaths. The ARR model significantly stratified the IgAN cohort according to risk of ESRD/death. The inclusion of eGFR and age significantly improved the ARR prognostic model; in the receiver operator characteristics (ROC) analysis, area under the curve (AUC) at 10-years of follow-up increased from 0.79 to 0.89, p < 0.001. Conclusions: ARR is a suitable prognostic model for stratifying IgAN patients according to the risk of ESRD or death. Including initial eGFR and age in the model substantially improved its accuracy in our nationwide cohort.

scholarly journals Phase I Dose Escalation Study To Evaluate the Safety and Pharmacokinetic Profile of Tefibazumab in Subjects with End-Stage Renal Disease Requiring Hemodialysis

2006 ◽  
Vol 50 (10) ◽  
pp. 3499-3500 ◽  
Author(s):  
Seth Hetherington ◽  
Michele Texter ◽  
Eric Wenzel ◽  
Joseph M. Patti ◽  
Laurie Reynolds ◽  
...  
Keyword(s):  
Body Weight ◽  
End Stage Renal Disease ◽  
Pharmacokinetic Profile ◽  
Volume Of Distribution ◽  
Average Volume ◽  
Dose Escalation Study ◽  
Elimination Half ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage

ABSTRACT Two cohorts of four subjects requiring hemodialysis received tefibazumab (10 or 20 mg/kg). The mean elimination half-life was between 17 and 18 days, the average volume of distribution was 7.3 liters, and the average clearance was 12 ml/h for both dose groups. At a dose of 20 mg/kg of body weight, plasma levels were 88 μg/ml at 21 days.

scholarly journals Correlation between Calcium Phosphorus Product and Mean Arterial Pressure among Hemodialysis Patients with End Stage Renal Disease

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Muhammad Nadeem ◽  
Mansoor Abbas Qaisar ◽  
Ali Hassan Al Hakami ◽  
Fateh Sher Chattah ◽  
Muhammad Muzammil ◽  
...  
Keyword(s):  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Renal Disease ◽  
End Stage Renal Disease ◽  
Hemodialysis Patients ◽  
Age Group ◽  
Calcium Phosphorus ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage

Background: The mean arterial pressure serves as an expression of blood pressure in patients on chronic hemodialysis. Serum calcium phosphorus product is considered as a risk factor of vascular calcification that is associated with hypertension in the patients of end stage renal disease. The literature regarding this relationship is inconsistent therefore this study is designed to determine the correlation between calcium phosphorus product and mean arterial pressure among hemodialysis patients with end stage renal disease. Methods: A total of 110 patients of end stage renal disease on hemodialysis for at least one year, 20 to 60 years of age were included. Patients with primary or tertiary hyperparathyroidism, peripheral vascular disease, malignancy, hypertension secondary to any cause other than kidney disease were excluded. Mean arterial pressure was calculated according to the standard protocol in lying position. Blood samples for estimation of serum calcium and phosphorous were taken and was sent immediately to the laboratory for serum analysis. Results: Mean age was 44.17 ± 10.94 years. Mean calcium phosphorous product was 46.71 ± 7.36 mg/dl and mean arterial pressure was 103.61 ± 12.77 mmHg. The values of Pearson correlation co-efficient (r) were 0.863 for age group 20 to 40 years and 0.589 for age group 41 to 60 years. This strong positive correlation means that high calcium phosphorous product goes with high mean arterial pressure (and vice versa) for both the age groups. Conclusion: A strong positive relationship exists between the mean arterial pressure and calcium phosphorous product and is independent of patients’ age.

scholarly journals CHILDRENONHEMODIALYSIS: A RETROSPECTIVESTUDYIN BENGHAZI PEDIATRIC HOSPITAL

2020 ◽  
Vol 8 (12) ◽  
pp. 827-832
Author(s):  
Narges M. Kablan ◽  
◽  
Khadija A. Ali ◽  
Kamlah J. Said ◽  
Mabroka A. Ali ◽  
...  
Keyword(s):  
Body Weight ◽  
White Blood Cells ◽  
Life Quality ◽  
Pediatric Hospital ◽  
Dialysis Unit ◽  
Major Health Problem ◽  
Drug History ◽  
Male Patients ◽  
Stage Renal Disease ◽  
End Stage

End stage renal disease (ESRD) is a major health problem worldwide. In Libya, limited studies are available on children with ESRD.Regular assessment of laboratory parameters is the only way to reduce their risk of mortality.This study aimed to determinethe demographic characteristics and evaluate the hematological profile of children on hemodialysis (HD) admitted to the dialysis unit in Benghazi Pediatric hospital, Benghazi, Libya during the period 3rd of December, 2017 to 15th of January 2018.A structured form was used to record data collected from patients files. Data includedage, gender, body weight, treatment history, drug history, duration and frequency of HD and laboratory tests results, specifically white blood cells (WBC), hemoglobin (HB), blood urea, glucose, Albumin, uric acid, serum creatinine, serum iron, calcium, phosphate, sodium and potassium.Number of patients on HD includedin this study was seven with average age of 11years,the majority (71%)were males.Average body weight of female patients was24.2kg,while male patients averagebody weight was25.52kg. Most of the patients(57%)hadhigh BP.71%of patientsstarted dialysis sincemore than one year.Patients underwentdialysisthree times a week represented(86%),while the rest of patients underwent dialysis four times a weekrepresented(14%).All patients had anemia and highcreatininelevel.Providing an appropriate care for children on maintenance dialysis in Libya is quitedifficult. Increasing the awareness ofparents about ESRD is necessary to improve the life quality of children with ESRD.

scholarly journals In-hospital mortality among incident hemodialysis older patients in Peru

2019 ◽  
Vol 12 (2) ◽  
pp. 142-147
Author(s):  
Percy Herrera-Añazco ◽  
Pedro J Ortiz ◽  
Jesus E Peinado ◽  
Tania Tello ◽  
Fabiola Valero ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Older Patients ◽  
Linear Models ◽  
Venous Catheter ◽  
Ageing Population ◽  
Middle Income ◽  
Middle Income Countries ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background Understanding the pattern of mortality linked to end stage renal disease (ESRD) is important given the increasing ageing population in low- and middle-income countries. Methods We analyzed older patients with ESRD with incident hemodialysis, from January 2012 to August 2017 in one large general hospital in Peru. Individual and health system-related variables were analyzed using Generalized Linear Models (GLM) to estimate their association with in-hospital all-cause mortality. Relative risk (RR) with their 95% confidence intervals (95% CI) were calculated. Results We evaluated 312 patients; mean age 69 years, 93.6% started hemodialysis with a transient central venous catheter, 1.7% had previous hemodialysis indication and 24.7% died during hospital stay. The mean length of stay was 16.1 days (SD 13.5). In the adjusted multivariate models, we found higher in-hospital mortality among those with encephalopathy (aRR 1.85, 95% CI 1.21-2.82 vs. without encephalopathy) and a lower in-hospital mortality among those with eGFR ≤7 mL/min (aRR 0.45, 95% CI 0.31-0.67 vs. eGFR&gt;7 mL/min). Conclusions There is a high in-hospital mortality among older hemodialysis patients in Peru. The presence of uremic encephalopathy was associated with higher mortality and a lower estimated glomerular filtration rate with lower mortality.

scholarly journals Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients

2018 ◽  
Vol 48 (4) ◽  
pp. 251-259 ◽  
Author(s):  
Jalal Azmandian ◽  
Mohammad Reza Abbasi ◽  
Vahid Pourfarziani ◽  
Amir Ahmad Nasiri ◽  
Shahrzad Ossareh ◽  
...  
Keyword(s):  
Body Weight ◽  
Hemodialysis Patients ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Epoetin Alfa ◽  
Double Blind ◽  
Epoetin Beta ◽  
Significant Difference ◽  
The Mean ◽  
Stage Renal Disease

Background: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. Methods: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10–12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. Results: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10–12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. Conclusion: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).

Peritoneal Dialysis in Iran and the Middle East

2009 ◽  
Vol 29 (2_suppl) ◽  
pp. 217-221 ◽  
Author(s):  
Iraj Najafi
Keyword(s):  
Saudi Arabia ◽  
Peritoneal Dialysis ◽  
Middle East ◽  
End Stage Renal Disease ◽  
National Income ◽  
Number Of Patients ◽  
The Mean ◽  
Per Capita ◽  
Stage Renal Disease ◽  
End Stage

The countries of the Middle East have a cumulative population of 261.1 million and a mean gross national income per capita of US$9500. The total number of patients with end-stage renal disease (ESRD) in the Middle East is almost 100000, the mean prevalence being 430 per million population (pmp). The first implementation of intermittent peritoneal dialysis (PD) in the Middle East occurred in Turkey in 1968; continuous ambulatory PD started in Saudi Arabia, Turkey, and Kuwait in the 1980s; and automated PD, in Turkey in 1998. The total active PD patients in the region number approximately 8170. With 5750 patients, Turkey ranks first, followed by Iran and Saudi Arabia with 1150 and 771 patients respectively. Penetration of PD with respect to the ESRD population is 7.5%, and with respect to dialysis overall is 10.2%. The dialysis rate in the region, 312 pmp, is almost half the European number of 581 pmp, with a PD prevalence of 32 pmp (range: 0 – 81 pmp). The number of active PD patients has risen dramatically in the main countries since the end of the 1990s: Turkey, to 5750 from 1030; Saudi Arabia, to 771 from 132; and Iran to 1150 from 0.

scholarly journals Optimization of busulfan dosage in children undergoing bone marrow transplantation: a pharmacokinetic study of dose escalation

Blood ◽  
1992 ◽  
Vol 80 (9) ◽  
pp. 2425-2428 ◽  
Author(s):  
AM Yeager ◽  
JE Jr Wagner ◽  
ML Graham ◽  
RJ Jones ◽  
GW Santos ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Body Weight ◽  
Bone Marrow Transplantation ◽  
Young Children ◽  
Marrow Transplantation ◽  
Antineoplastic Agent ◽  
Area Under The Curve ◽  
Therapeutic Effects ◽  
Older Children ◽  
The Mean

Abstract Busulfan (BU) is a widely used myeloablative and antineoplastic agent in clinical bone marrow transplantation (BMT). The lower incidence of BU-associated toxicities and lower therapeutic effectiveness in young children given BU doses based on body weight (ie, 16 mg/kg) is associated with altered pharmacokinetics of BU; the area under the curve (AUC) of BU concentration versus time is significantly less in these patients than those observed in older children and adults. To optimize BU dosage in young BMT recipients, we developed a dosage regimen based on body surface area (BSA) and determined BU pharmacokinetics and BU-associated toxicities. Seven children (median age, 3.9 years, range, 1.1 to 5.7) undergoing allogeneic or autologous BMT for leukemia received 40 mg/m2/dose BU every 6 hours for 16 doses; BU concentrations were measured in the plasma, and AUCs were determined for each patient after the first and 13th doses. Expressed as a function of body weight, the median BU dosage was 26.4 mg/kg (range, 24.3 to 28.2), a 60% increase over the BU dosage based on body weight. Four patients developed mucositis, and one of them also developed nonfatal hepatic veno-occlusive disease (VOD). No patients receiving 40 mg/m2 BU developed neurotoxicity (eg, seizures) or interstitial pneumonitis. Prompt and sustained engraftment was observed in the allogeneic BMT recipients, and late graft failure was not seen. The mean BU AUCs were 1,105 mumol/L.min (range, 790 to 2,080) after the first dose and 1,022 mumol/L.min (range, 632 to 1,860) after the 13th dose of BU, comparable to the AUCs in adults given 16 mg/kg of BU. These studies suggest that, in young children, BSA-based dosing of BU (40 mg/m2) provides drug exposures (AUCs) closer to adult values with acceptable toxicities and may improve therapeutic effects.

P1424IMPACT OF DIRECTLY OBSERVED TREATMENT OF ONE ALFACALCIDOL ON MINERAL BONE DISORDER PROFILE IN DIALYSIS PATIENTS-A SINGLE UNIT PILOT STUDY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Mirza Yasar Baig ◽  
Rajkumar Chinnadurai ◽  
Tina Chrysochou
Keyword(s):  
Pilot Study ◽  
End Stage Renal Disease ◽  
Single Unit ◽  
Dialysis Patients ◽  
Mineral Bone Disorder ◽  
Bone Disorder ◽  
Directly Observed Treatment ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage

Abstract Impact of directly observed treatment of one-alfacalcidol on mineral bone disorder profile in dialysis patients- A single unit pilot study Background and Aims Secondary hyperparathyroidism (SHPT) is a common mineral bone disorder observed in patients with end-stage renal disease. Management of SHPT can be challenging mainly due to poor medication compliance. Directly observed treatment (DOT) has shown to improve management outcomes in other conditions like tuberculosis. We conducted a pilot study to investigate the impact of DOT with one alfacalcidol for SHPT in our cohort of dialysis patients. Method This prospective observational study was conducted on 21 end stage renal disease patients on dialysis from a single centre who were commenced on one alfacalcidol on dialysis days under direct observation .All patients had not shown any improvement in PTH despite increase in one alfacalcidol either admitted to or were suspected to have medication non-adherence. Serum bone mineral profile including parathormone (PTH), corrected calcium, phosphate and alkaline phosphatase were recorded before and after initiation of DOT. Treatment outcome was measured by comparing the mean change in the biochemical profile prior DOT initiation and at the lowest PTH value achieved on DOT. Data was analysed by paired t test using SPSS software. Results The mean age of our sample at the time of commencing DOT therapy was 52 years. Our sample had a predominance of males (67%) and Asian ethnicity (62%). 71% had a history of hypertension and 43% were diabetic. DOT one alfacalcidol therapy produced a significant reduction in the mean PTH value (pre-DOT- 92.2 vs post DOT-36.1 pmol/L, p&lt;0.001). There was a significant rise in the corresponding mean corrected calcium levels (pre-DOT- 2.22 vs post-DOT-2.45 mmol/L, p=0.001) (table–1). Over a mean follow up of 8 months, a significant reduction in the one alfacalcidol dose requirement was observed in 52.38% of our cohort. Conclusion DOT one alfacalcidol therapy produced a significant improvement in the mineral bone profile in our cohort of dialysis patients. DOT approach can help to improve the outcomes in dialysis patients with poor compliance.

Pharmacokinetics of lenalidomide in subjects with various degrees of renal function

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2520-2520
Author(s):  
N. Chen ◽  
H. Lau ◽  
L. Kong ◽  
J. Zeldis ◽  
R. Knight ◽  
...  
Keyword(s):  
Renal Function ◽  
Creatinine Clearance ◽  
Strongly Correlated ◽  
Pooled Data ◽  
Safety Parameters ◽  
Immunomodulatory Drug ◽  
The Mean ◽  
Stage Renal Disease ◽  
End Stage ◽  
Initial Starting

2520 Background: Lenalidomide is a novel oral immunomodulatory drug approved for treating myelodysplastic syndrome (MDS) and multiple myeloma (MM). As unchanged lenalidomide is eliminated predominantly by urinary excretion, the present study investigated the effect of renal impairment (RI) on pharmacokinetics (PK) of lenalidomide. Results were used to refine initial dosing recommendations based on a subject’s estimated creatinine clearance. Methods: The study was conducted at 3 clinical centers. Thirty male and female subjects aged 39–76 years were stratified into 5 groups based on their creatinine clearance (CLCr) values: normal renal function (NRF) (CLCr > 80 mL/min; N = 7), mild RI (50 = CLCr = 80 mL/min; N = 5), moderate RI (30 = CLCr < 50 mL/min; N = 6), severe RI (CLCr < 30 mL/min, but not on dialysis; N = 6), and end stage renal disease (ESRD, requiring dialysis; N = 6). Subjects with NRF, mild, moderate or severe RI received a single 25-mg oral dose of lenalidomide. Subjects with ESRD received 2 single 25 mg doses which were separated by 7–10 days: one dose on a non-dialysis day and the other dose 3 hours before a 4-hour haemodialysis. Assessments included PK and safety parameters. Results: All subjects completed the study. Total and renal clearance of lenalidomide were strongly correlated with CLCr (R > 0.9, p < 0.01). As a result, AUC8 increased with decreasing CLCr. The mean difference in AUC8 between NRF and mild RI was < 20%. Compared with the pooled data from NRF and mild RI groups, mean AUC8 increased approximately 140% in moderate RI, 240% in severe RI, and 360% in ESRD (off dialysis). There was no correlation between Cmax or Tmax and CLCr. Approximately 10% of the dose was recovered in the dialysate of subjects with ESRD. Protein binding of lenalidomide was not markedly affected by RI (∼35 - 44%). The drug was well tolerated. On the basis of these data, recommendations for initial starting doses were made ( Table below). Conclusions: Lenalidomide dosage adjustment should be considered for patients with CLCr < 50 mL/min. [Table: see text] No significant financial relationships to disclose.

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