scholarly journals SP554LOW LEVELS OF SERUM FERRITIN WITH MODERATE LEVEL OF TRANSFERRIN SATURATION MAINTAINS ADEQUATE ANEMIA CONTROL IN HEMODIALYSIS PATIENTS TREATED WITH DARBEPOETIN ALFA

2016 ◽  
Vol 31 (suppl_1) ◽  
pp. i276-i277
Author(s):  
Chie Ogawa ◽  
Ken Tsuchiya ◽  
Fumiyoshi Kanda ◽  
Kunimi Maeda
Keyword(s):  
Serum Ferritin ◽  
Darbepoetin Alfa ◽  
Transferrin Saturation ◽  
Hemodialysis Patients ◽  
Moderate Level

scholarly journals FP655LOW LEVELS OF SERUM FERRITIN WITH MODERATE LEVEL OF TRANSFERRIN SATURATION MAINTAINS ADEQUATE HEMOGLOBIN IN HEMODIALYSIS PATIENTS

2015 ◽  
Vol 30 (suppl_3) ◽  
pp. iii292-iii293
Author(s):  
Chie Ogawa ◽  
Ken Tsuchiya ◽  
Fumiyoshi Kanda ◽  
Kunimi Maeda ◽  
Teiryo Maeda
Keyword(s):  
Serum Ferritin ◽  
Transferrin Saturation ◽  
Hemodialysis Patients ◽  
Moderate Level

MO559ASCEND-ND: STUDY DESIGN AND BASELINE CHARACTERISTICS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Vlado Perkovic ◽  
Allison Blackorby ◽  
Borut Cizman ◽  
Kevin Carroll ◽  
Alexander Cobitz ◽  
...  
Keyword(s):  
Serum Ferritin ◽  
Darbepoetin Alfa ◽  
Trial Design ◽  
Rescue Therapy ◽  
Transferrin Saturation ◽  
Statistical Testing ◽  
Efficacy And Safety ◽  
Primary Endpoints ◽  
History Of ◽  
Baseline Characteristics

Abstract Background and Aims The Anemia Study in Chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor (PHI) Daprodustat-Non-Dialysis (ASCEND-ND; NCT02876835) trial is evaluating the efficacy and safety of daprodustat when compared with darbepoetin alfa in CKD patients with anaemia not requiring dialysis. We report the trial design as well as key baseline characteristics of participants. Method Eligible patients from 39 countries were adults with CKD stages 3–5 who were able to provide informed consent and demonstrated adherence to daprodustat placebo tablets and study procedures during the run-in period. Patients were eligible if (1) they were not using erythropoiesis stimulating agents (ESAs) and had a screening haemoglobin (Hb) 8 to 10 g/dL or if (2) they were receiving ESAs with screening Hb of 8 to 12 g/dL. Patients were required to be iron replete [transferrin saturation (TSAT) >20% and serum ferritin >100 ng/mL] at screening. Participants were randomised to daprodustat or darbepoetin alfa (1:1) in an open-label (sponsor-blind) trial design with blinded endpoint assessment. An IDMC conducts regular reviews of unblinded safety and efficacy data and makes recommendations for additions or adjustments. An external, independent and blinded Clinical Events Classification (CEC) group, led by the Duke Clinical Research Institute, in collaboration with George Clinical, adjudicate predefined events. During the study, both groups had randomised treatment adjusted using a protocol-defined algorithm targeting a Hb range of 10 to 11 g/dL. Participants also followed protocol-defined iron management criteria to ensure they remained iron replete. Additionally, an anaemia rescue algorithm was in place to minimise the risk of extended periods of inadequate Hb response and to ensure consistent application of rescue therapy across the study. The co-primary endpoints are mean change in Hb between baseline and Evaluation Period (EP; Weeks 28 to 52, inclusive) and time to first adjudicated major adverse cardiovascular event (MACE; composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke). The study has more than 99% power for the Hb non-inferiority (NI) test with an NI margin of -0.75 g/dL for the treatment difference of mean change in Hb between baseline and EP, and approximately 90% power to exclude the NI margin of 1.25 for time to first adjudicated MACE, for daprodustat compared with darbepoetin alfa. Conditional on both co-primary endpoints achieving NI at the one-sided 2.5% level, statistical testing will progress to evaluate MACE and the principal secondary endpoint of CKD progression for superiority. These tests will be multiplicity adjusted. Results A total of 3872 patients were randomised (median age 67 years, 56% female; 55% white, 28% Asian, and 10% black). The median baseline Hb was 9.8 g/dL, serum ferritin was 274 ng/mL, TSAT 30%, and eGFR 18 mL/min/1.73 m2. Among randomised patients, 54% were ESA non-users, 57% reported a history of diabetes mellitus and 36% a history of cardiovascular disease. Median blood pressure was 135/74 mmHg. Sixty percent of participants were taking angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, while 57% were taking lipid modifying agents at baseline. The trial is expected to complete during 2021. Conclusion ASCEND-ND will define the efficacy and safety of daprodustat compared with darbepoetin alfa in the treatment of patients with anaemia associated with CKD not requiring dialysis.

P1407LIVER, HEART AND BONE: THE PATH OF IRON OVERLOAD IN HEMODIALYSIS PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Lucas Acatauassu Nunes ◽  
Luciene Reis ◽  
Hanna Machado ◽  
Rosse Osório ◽  
Rosa Moyses ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Remodeling ◽  
Serum Ferritin ◽  
Bone Biopsy ◽  
Saturation Index ◽  
Transferrin Saturation ◽  
Hemodialysis Patients ◽  
High Serum ◽  
Cross Sectional ◽  
Osteoblast Activity

Abstract Background Chronic kidney disease (CKD) is associated with several comorbidities, including anemia, since with decreased renal function there is a decrease in erythropoietin (EPO) production and changes in iron (Fe) metabolism. In hemodialysis patients, prescription of Fe is indicated to supplement the needs of this element by maintaining ferritin levels above 100 mg/dl and transferrin saturation greater than 20%. However, the excess of Fe can generate free Fe not bound to transferrin, and deposit in organs such as liver, heart, and bone marrow, with consequent impairment of their function. In hemodialysis patients, the diagnosis of Fe overload, its clinical significance and therapeutic decision have been poorly studied, unlike thalassemia patients. Aims To assess whether hemodialysis patients with ferritin levels equal to or greater than 1000 mg/l also have Fe overload in liver, heart, and bone marrow, as well as compromise bone density and remodeling. Method This is a cross-sectional analysis that included 28 adult patients on regular conventional hemodialysis. Inclusion criteria were serum levels of ferritin ≥ 1000 mg/l, and ESRD treated by regular hemodialysis for at least 6 months. We excluded patients with HIV, cancer, hepatic disease, patients who received desferroxamine in the latest year, and those previously submitted to a kidney transplant. All patients underwent dual-energy X-ray absorptiometry (DXA), serum ferritin, transferrin saturation index (STI), Fe, C reactive protein (CRP), Calcium(Ca), phosphorus (P), parathyroid hormone (PTH) and alkaline phosphatase (AP) levels were recorded. T2* image acquisition of Magnetic Resonance Imaging (MRI) 1,5 Tesla, were used for the assessment of Fe of liver, and heart. R2* and R2* Water were used of liver and bone (iliac crest). Bone biopsy was also performed. Results We evaluated 28 hemodialysis patients with a mean age of 55.8±13.1, hemodialysis time of 42.5±26.5 and iron use in the year prior to study enrollment of 311.5±179.8 mg/month. Biochemical analysis showed 3 patients with Hb below 9.0 mg/dl and 14 with values above 11.5 mg/dl; 6 patients with SatFe <30% and 12 patients with ferritin >1500mg/dl; 16 patients with PTH <300pg/ml and eight with >600pg/dl. MRI revealed Fe overload in the liver and bone tissue (figure 1) of all patients but not in the heart. Serum ferritin levels correlated with liver and bone overload (figure 2). Densitometry and bone biopsy results were not affected by Fe overload, however, serum Fe levels were associated with lower bone remodeling and mineralization suggesting an effect of this element on osteoblast activity. Conclusion High serum ferritin is associated with liver and bone marrow Fe overload, but not heart, as well as with low bone remodeling and mineralization. We must be aware of these side effects of high doses of Fe that are commonly used in these patients.

scholarly journals Predictors of the response to treatment in anemic hemodialysis patients with high serum ferritin and low transferrin saturation

2007 ◽  
Vol 71 (11) ◽  
pp. 1163-1171 ◽  
Author(s):  
A.K. Singh ◽  
D.W. Coyne ◽  
W. Shapiro ◽  
A.R. Rizkala ◽  
the DRIVE Study Group
Keyword(s):  
Serum Ferritin ◽  
Transferrin Saturation ◽  
Hemodialysis Patients ◽  
High Serum ◽  
Response To Treatment

scholarly journals Optimization of Epoetin Therapy with Intravenous Iron Therapy in Hemodialysis Patients

2000 ◽  
Vol 11 (3) ◽  
pp. 530-538
Author(s):  
ANATOLE BESARAB ◽  
NEETA AMIN ◽  
MUHAMMAD AHSAN ◽  
SUSAN E. VOGEL ◽  
GARY ZAZUWA ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Transferrin Saturation ◽  
Intravenous Iron ◽  
Hemodialysis Patients ◽  
Chronic Hemodialysis ◽  
Control Group ◽  
Zinc Protoporphyrin ◽  
Study Group ◽  
Iron Deficient

Abstract. Iron deficiency limits the efficacy of recombinant human erythropoietin (rhEPO) therapy in end-stage renal disease (ESRD) patients. Functional iron deficiency occurs with serum ferritin >500 ng/ml and/or transferrin saturation (TSAT) of 20 to 30%. This study examines the effects of a maintenance intravenous iron dextran (ivID) protocol that increased TSAT in ESRD hemodialysis patients from conventional levels of 20 to 30% (control group) to those of 30 to 50% (study group) for a period of 6 mo. Forty-two patients receiving chronic hemodialysis completed a 16- to 20-wk run-in period, during which maintenance ivID and rhEPO were administered in amounts to achieve average TSAT of 20 to 30% and baseline levels of hemoglobin of 9.5 to 12.0 g/dl. After the run-in period, 19 patients randomized to the control group received ivID doses of 25 to 150 mg/wk for 6 mo. Twenty-three patients randomized to the study group received four to six loading doses of ivID, 100 mg each, over a 2-wk period to achieve a TSAT >30% followed by 25 to 150 mg weekly to maintain TSAT between 30 and 50% for 6 mo. Both regimens were effective in maintaining targeted hemoglobin levels. Fifteen patients in the control group and 17 patients in the study group finished the study in which the primary outcome parameter by intention to treat analysis was the rhEPO dose needed to maintain prestudy hemoglobin levels. Maintenance ivID requirements in the study group increased from 176 to 501 mg/mo and were associated with a progressive increase in serum ferritin to 658 ng/ml. Epoetin dose requirements for the study group decreased by the third month and remained 40% lower than for the control group, resulting in an overall cost savings in managing the anemia. Secondary indicators of iron-deficient erythropoiesis were also assessed. Zinc protoporphyrin did not change in either group. Reticulocyte hemoglobin content increased only in the study group from 28.5 to 30.1 pg. It is concluded that maintenance of TSAT between 30 and 50% reduces rhEPO requirements significantly over a 6-mo period.

Intravenous (IV) Iron Supplementation in Patients with Chemotherapy-Induced Anemia (CIA) Receiving Darbepoetin alfa Every 3 Weeks (Q3W): Iron Parameters in a Randomized Controlled Trial.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1552-1552 ◽  
Author(s):  
Christian Lerchenmueller ◽  
Faress Husseini ◽  
Bernd Gaede ◽  
Tony Mossman ◽  
Tamas Suto ◽  
...  
Keyword(s):  
Serum Ferritin ◽  
Darbepoetin Alfa ◽  
Iron Supplementation ◽  
Transferrin Saturation ◽  
Oral Iron ◽  
Ferritin Concentration ◽  
Standard Practice ◽  
Serum Ferritin Concentration ◽  
Iv Iron ◽  
Iron Parameters

Abstract Background and Aim: The role of IV iron supplementation during treatment with erythropoiesis-stimulating agents (ESAs) in patients with CIA is of increasing interest as a possible means of improving response. This randomized, open-label, multicenter study was designed to evaluate the safety and efficacy of IV iron vs standard practice in CIA patients receiving darbepoetin alfa. Interim efficacy analyses showed a higher response rate for darbepoetin alfa with IV iron compared to darbepoetin alfa with standard iron practice with no difference in the safety profile between the treatment arms (Vanderbroek et al, EHA 2006). Iron parameters are reported here. Methods: Eligible patients were diagnosed with a non-myeloid malignancy and had CIA with a baseline hemoglobin (Hb) value < 11g/dL. All patients received darbepoetin alfa 500 mcg administered Q3W with the SureClick™ prefilled autoinjector. Patients were randomized 1:1 to IV iron 200 mg (single dose Q3W at the same time as darbepoetin alfa or in 2 doses of 100 mg within 3 weeks) or standard practice (oral iron or no iron). Randomization was stratified by tumor type and baseline Hb category (< 10 or ≥10 g/dL). Results: A total of 400 patients were randomized. Mean (SD) age of the study population was 61.4 (11.5) years; range, 20–86. Sixty percent (n=241) of participants were women; 28% (n=114) had lung or gynecological tumors; and 52% (n=208) had a baseline Hb value ≥10 g/dL. In the interim analysis population (n=196), the mean (SD) weekly dose of IV iron was 64.8 (6.6) mg in the IV iron group (n=100). In the standard practice group, 28 of 96 patients (29%) received oral iron and 2 (2%) received IV iron (these patients were analyzed as randomized). Mean (standard error) serum ferritin concentrations and percent transferrin saturation (TSAT) in the 2 groups from baseline (BL) to end of study (EOS) are shown in the figure. Conclusions: The combination of darbepoetin alfa Q3W and IV iron appeared to be associated with a trend toward increased mean serum ferritin levels compared to the standard practice control arm. In contrast, mean TSAT surprisingly appeared to be similar in the 2 groups for most of the study period, perhaps suggesting that TSAT is influenced by other factors. Iron management appears to be an important factor in the response to ESAs and the findings presented here suggest the need for additional exploration into iron uptake and demand in cancer patients treated with darbepoetin alfa. Serum Ferritin Concentration Serum Ferritin Concentration Transferrin Saturation (%) Transferrin Saturation (%)

scholarly journals The evaluation of iron status in hemodialysis patients.

1996 ◽  
Vol 7 (12) ◽  
pp. 2654-2657 ◽  
Author(s):  
S Fishbane ◽  
E A Kowalski ◽  
L J Imbriano ◽  
J K Maesaka
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Marginal Utility ◽  
Iron Status ◽  
Transferrin Saturation ◽  
Hemodialysis Patients ◽  
Mean Cell Volume ◽  
Distribution Width ◽  
Baseline Serum ◽  
Significant Difference

Effective treatment of anemia in hemodialysis patients requires ongoing monitoring of iron status. The purpose of this study was to determine levels of commonly used iron indices predictive of iron deficiency in this population. Forty-seven patients with baseline serum ferritin levels < 600 ng/mL were treated with intravenous iron dextran (INFeD; Schein Pharmaceutical Inc., Florham Park, NJ), 1000 mg over ten hemodialysis treatments. Patients whose hematocrit value increased by 5% or who had a 10% decrease in their erythropoietin dose by 2 months were classified as having iron deficiency (N = 31; 66%). All other subjects were classified as having adequate iron (N = 16; 34%). There was no statistically significant difference in baseline serum ferritin, transferrin saturation, mean cell volume, mean cell hemoglobin content, or red cell distribution width between the two groups. Receiver operator curves demonstrated that none of the iron indices had a high level of utility (both sensitivity and specificity > 80%). Two tests had marginal utility, serum ferritin at a level of < 150 ng/mL, and transferrin saturation < 21%. It was concluded that because of the tests' marginal utility, they should only be interpreted in the context of the patient's underlying erythropoietin, responsiveness. In patients who are responsive to erythropoietin, a transferrin saturation value < 18% or serum ferritin level < 100 ng/mL should be used to indicate inadequate iron. When erythropoietin resistance is present, transferrin saturation of < 27% or serum ferritin < 300 ng/mL should be used to guide iron management.

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