***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: Introduction The aim of this trial was to gather data on the long-term safety of a new erythropoietin preparation ( epoetin zeta ) , focusing on the formation of anti-erythropoietin antibodies , when administered intravenously for maintenance of target hemoglobin concentration in anemic patients with end-stage renal failure receiving chronic hemodialysis . In addition , we aim ed to provide information on the efficacy of epoetin zeta under open , noncontrolled conditions . Methods Patients received epoetin zeta intravenously , 1–3 times/week for 56 weeks ( overall patient group , n=745 ) or 108 weeks ( Bulgarian subgroup , n=164 ) . The aim of treatment was to maintain hemoglobin values between 10.5 and 12.5 g/dL with constant epoetin dosage . Primary ( safety ) endpoints were the occurrence of anti-erythropoietin antibodies and the evaluation of adverse events ( AEs ) . Secondary ( efficacy ) endpoints included the mean weekly dose of epoetin per kg of body weight and mean hemoglobin concentrations . Results No patients developed neutralizing anti-erythropoietin antibodies . The most commonly reported AEs were infections and infestations ( 34.1 % ) ; followed by injury , poisoning , and procedural complications ( 25.8 % ) ; and gastrointestinal disorders ( 21.9 % ) ; 37.3 % of patients reported serious AEs . The hemoglobin values remained stable , with mean values after 56 weeks of 11.3–11.6 g/dL for the overall group and 11.1–11.6 g/dL for the Bulgarian subgroup . The dosage of epoetin zeta was stable throughout the course of the trial . No cases of lack of ( or loss of ) efficacy were observed in the course of the trial . Conclusions The evaluation of the primary endpoints provided data supporting the intravenous administration of epoetin zeta in patients with chronic renal failure .  Neutralizing antibodies against erythropoietin were not detected , and there were no reports of patients with increasing erythropoietin resistance . Our results suggest that intravenous administration of epoetin zeta is effective regarding its ability to maintain stabilized hemoglobin levels within the target range of 10.5–12.5 While recombinant human erythropoietin ( rHuEPO ) is an effective therapy for anemia in renal failure , most published studies concern benefits in relatively healthy hemodialysis patients . The present study compares intravenous and subcutaneous administration of rHuEPO in an unselected group of 128 hemodialysis patients who were r and omized to receive rHuEPO  in an initial dose of 150 U/kg/week in three divided doses by subcutaneous or intravenous injection . Following a 4-week placebo run-in period , patients received rHuEPO until their hemoglobin was stable between 105 and 125 g/l for 4 weeks and then followed for a further 24 weeks . Eighty-three patients completed the study , 45 in the subcutaneous and 38 in the intravenous group . There was no difference in mean hemoglobin at any stage between subcutaneous and intravenous patients . Mean rHuEPO dose at the time of stabilization was significantly lower in the subcutaneous group compared to the intravenous ( 205.9 + /- 135.4 vs. 274.1 + /- 142.4 U/kg/week ; p = 0.019 ) , mean time to hemoglobin target was 9.9 + /- 4.5 weeks for the subcutaneous group and 11.9 + /- 4.9 weeks for the intravenous group ( p = 0.037 ) . Time to stabilization was 14.9 + /- 4.7 weeks for the subcutaneous compared to 17.3 + /- 3.9 weeks for the intravenous group ( p = 0.006 ) . Diabetic patients had higher dose requirements for  rHuEPO at all time points and required a longer time to reach stabilization than nondiabetics ( 18.6 + /- 4.6 vs. 15.6 + /- 4.3 weeks ; p = 0.016 ) . Quality of life estimated by a disease-specific Kidney Disease Question naire improved significantly during rHuEPO therapy in both groups . There was no significant change in dialysis prescription throughout the study . ( ABSTRACT TRUNCATED AT 250 WORDS The Normal Hematocrit Trial ( NHT ) was the largest trial of epoetin r and omizing 1265 hemodialysis patients with cardiac disease to lower ( 9–11 g/dl ) or higher ( 13–15 g/dl ) hemoglobin ( Hgb ) , hypothesizing that higher Hgb would reduce mortality , and improve survival and quality of life . The trial was terminated early , and a 1998 publication reported that targeting higher hematocrit levels led to an insignificant increase in the primary end points ( death or myocardial infa rct ) , or risk ratio 1.3 , 95 % confidence interval ( CI ) , 0.9–1.90 , but the P-value was not given , and all-cause death risk was not reported . A higher target reportedly did not increase hospitalization rates , but did significantly improve the ‘ physical function ' domain of quality of life . Comparing the 1996 Food and Drug Administration ( FDA ) -filed clinical trial report to the 1998 publication , however , found several discrepancies . Among these , the 1998 article reported interim trial results with only the adjusted CI but did not state that the unadjusted CIs were 99.912th percentile , and despite being a secondary end point , reported only the association of achieved Hgb with higher quality of life score . R and omization to the higher target had actually increased the risk for the primary end point ( risk ratio 1.28 , 95 % CI=1.06–1.56 ; P=0.0112 ; 99.92 % CI=0.92–1.78 ) , the risk of death ( risk ratio 1.27 , 95 % CI=1.04–1.54 ) , non-access thrombotic events ( P=0.041 ) , and hospitalization rate ( P=0.04 ) , while ‘ physical function ' did not improve ( P=0.88 ) . Hence , disclosure of these results in the 1998 publication or access to the FDA -filed report on the NHT in the late 1990s would likely have led to earlier concerns about epoetin safety and greater doubts about its benefits BACKGROUND The Dialysis Outcomes and Practice Patterns Study ( DOPPS ) is a prospect i ve , observational study based on data collected from nationally representative sample s of haemodialysis facilities . The burden of anaemia in haemodialysis patients is substantial , leading to considerable morbidity , mortality and reduced quality of life . This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS : France , Germany , Italy , Spain and the UK . METHODS Baseline data on demographics , co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998 - 2000 . Using multivariate Cox survival analyses to adjust for patient characteristics , relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated . RESULTS For a year 2000 sample of prevalent patients on haemodialysis > 180 days , mean haemoglobin concentration was 11.0 g/dl ; 53 % had a haemoglobin concentration > or = 11 g/dl [ 1998 - 1999 = 44 % ( P < 0.05 ) ] . In 2000 , 84 % of prevalent patients were prescribed recombinant human erythropoietin ( rHuEpo ) . Higher haemoglobin concentrations were associated with decreased relative risk ( RR ) for mortality ( RR = 0.95 for every 1 g/dl higher haemoglobin , P = 0.03 ) and hospitalization ( RR = 0.96 , P = 0.02 ) . Patients with haemoglobin < 10 g/dl were 29 % more likely to be hospitalized than patients with haemoglobin 11 - 12 g/dl ( P < 0.001 ) . CONCLUSION Even after adjustment , lower haemoglobin concentrations were associated with higher morbidity and mortality in European haemodialysis patients . A trend to increased haemoglobin concentrations was observed following publication of the European Best Practice Guidelines ( EBPG ) on anaemia management for chronic kidney disease patients , but efforts must continue to achieve EBPG goals BACKGROUND AND OBJECTIVES The effects of different hemoglobin targets when using erythropoiesis-stimulating agents on quality of life are somewhat controversial , and predictors of change in quality of life in endstage renal disease have not been well characterized . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were r and omly assigned to hemoglobin targets of 9.5 to 11.5 g/dl or 13.5 to 14.5 g/dl for 96 weeks , using epoetin_alfa as primary therapy . Patients and attending physicians were masked to treatment assignment . Quality of life , a secondary outcome , was prospect ively recorded using the Kidney Disease Quality of Life ( KDQoL ) question naire at weeks 0 , 24 , 36 , 48 , 60 , 72 , 84 , and 96 , with prespecified outcomes being fatigue and quality of social interaction . RESULTS The mean age and prior duration of dialysis therapy of the study population were 50.8 and 0.8 yr . Mortality was low , reflecting the relatively healthy group enrolled . Of 20 domains within the KDQoL only the prespecified domain of fatigue showed significant change over time between the two groups . Improvement in fatigue scores in the high-target group ranged from 3.2 to 7.9 over time ( P = 0.007 ) compared with change in the low-target group . Higher body mass index and lower erythropoietin dose at baseline were independent predictors of improvement in multiple KDQoL domains . CONCLUSIONS In relatively healthy hemodialysis patients , normal hemoglobin targets may have beneficial effects on fatigue . Improvement in multiple domains of quality of life is associated with higher body mass index and lower erythropoietin requirements The risks/ benefits of anemia treatment in dialysis patients have been redefined in the US Epoetin α label . This analysis was carried out to determine if increasing hemoglobin ( Hb ) levels improve exercise tolerance and physical function in anemic dialysis patients . This is a new analysis of the Canadian Erythropoietin Study Group trial , a double-blind , r and omized , placebo-controlled trial in dialysis patients . Subjects were 18 to 75 years old , on hemodialysis for > 3 months , and had a baseline Hb < 9.0 g/dL. Patients with a history of diabetes mellitus , ischemic heart disease , or severe/uncontrolled hypertension were excluded . Patients were r and omized to receive Epoetin α to a target Hb of 9.5 to 11.0 g/dL ( n=40 ) or a target of 11.5 to 13.0 g/dL ( n=38 ) , or receive placebo ( n=40 ) . Results from patients in the Epoetin-α-treated arms were combined for this analysis . Hb level , exercise tolerance ( Treadmill Stress Test and 6-Minute Walk Test ) and patient-reported physical function measures ( Physical Summary domain from the Kidney Disease Question naire , and 4 domains from the Sickness Impact Profile ) were reported at baseline and months 2 , 4 , and 6 . Differences in measures were statistically significant for exercise tolerance ( Treadmill Stress , P=0.0001 ) and patient-reported physical function ( Kidney Disease Question naire Physical , P=0.0001 ; Sickness Impact Profile Physical , P=0.0015 ) across all time points for Epoetin-α-treated patients compared with placebo . Improvements were seen at 2 months and were maintained through months 4 and 6 . Dialysis patients receiving Epoetin α  showed improved exercise tolerance and physical function . These findings should be considered as physicians weigh the risks and benefits of treatment BACKGROUND Increased hemoglobin ( Hb ) levels and higher blood viscosity could reduce hemodialyzer clearance . We examined hemodialysis ( HD ) adequacy after treatment with epoetin alfa aim ed at normalizing Hb levels . METHODS Thirty-three HD patients were r and omly allocated to achieve a normal Hb level ( 135 - 160 g/L ) or a subnormal ( control ) Hb level of 90 - 120 g/L. HD adequacy was assessed by Kt/V measurement . RESULTS In the 24 evaluable patients , Hb levels reached 144 + /- 11 g/L in the normal Hb group ( n=10 ) and 109 + /- 10 g/L in the subnormal group ( n=14 ) . Single-pool Kt/V decreased from 1.25 + /- 0.19 to 1.15 + /- 0.13 ( p<0.01 ) in the normal Hb group , but remained 
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However , no benefits have been found in relation to mortality rates and non-cardiac fatal events , except quality of life .
We found no evidence to assess the benefits and harms of early versus delayed EPO for the anaemia of ESKD