SO050DIFFERENT FERRIC CITRATE DOSE REGIMENS IN THE TREATMENT OF IRON DEFICIENCY ANAEMIA IN PATIENTS WITH NON-DIALYSIS-DEPENDENT CKD: THE COMPASS TRIAL

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Pablo Pergola ◽  
Diogo Belo ◽  
Paul Crawford ◽  
Moustafa Moustafa ◽  
Dennis Vargo ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Transferrin Saturation ◽  
Adult Patients ◽  
Ferric Citrate ◽  
Dose Titration ◽  
Open Label ◽  
Deficiency Anaemia ◽  
Ckd Stage ◽  
Dosing Regimens

Abstract Background and Aims Ferric citrate (FC) is approved in the US as oral iron replacement for the treatment of iron deficiency anaemia (IDA) in adult patients with non-dialysis dependent (NDD) chronic kidney disease (CKD) and for the treatment of hyperphosphatemia in adult patients with dialysis dependent CKD. For IDA, a starting dose FC of 1 tablet three times daily (TID) is recommended with titration to maintain haemoglobin (Hb) at goal. This study was designed to investigate the possibility of dosing FC twice daily (BID) for flexibility in clinical practice. The efficacy and safety of different FC dosing regimens for the treatment of IDA were examined in adults with NDD-CKD. Method In this 48-wk, Phase 4, randomized, open-label, multicentre study, subjects with IDA of NDD-CKD (stage 3-5) were randomized 1:1 to receive 1 FC tablet (1gm containing 210mg ferric iron) TID or 2 tablets BID. At wk 12, subjects whose Hb increased <0.5 g/dL from baseline (BL) or was <10 g/dL had their dose increased to either 2 tablets TID or 3 tablets BID consistent with their original dosing regimen. This prespecified analysis reports data through wk 24. The primary endpoint was mean change in Hb from BL to wk 24. Secondary endpoints included mean change in transferrin saturation (TSAT), ferritin, and phosphate to wk 24. Results 206 subjects were randomized, 183 were included in this analysis after completing the 24-wk dose titration period. Groups were well matched with mean age of 69.5 +/- 10.32 years, 64% female and 54% had diabetes as a cause of CKD. Mean BL eGFR was 33.6 +/- 10.85 ml/min/1.73m2 and Hb 10.45 +/-0.744 g/dL. In subjects who did not require an increase in the FC dose at wk 12, mean changes in Hb at wk 24 were 1.05 and 1.24 g/dL in the 1 tablet TID and 2 tablet BID dosage groups, respectively. In subjects who required an increase in the FC dose at wk 12, mean changes in Hb at wk 24 were 0.41 and 0.13 g/dL in the 2 tablet TID and 3 tablet BID groups, respectively. Mean changes in TSAT, ferritin and phosphate are presented in the Table. The incidence of TEAEs was 78.2% and 75.0% in the BID and TID groups, respectively. The most common AEs reported were diarrhoea, stool discoloration and constipation. The incidence of SAEs was 13.9% and 17.3% in the BID and TID groups, respectively. Five deaths were reported, none were deemed related to FC per the investigator. Conclusion FC was effective and generally well tolerated in the treatment of IDA in this NDD-CKD population. Subjects who had per protocol FC dose increases at wk 12 had less pronounced iron deficiency at BL and smaller increases in Hb suggesting an additional underlying cause of anaemia. Mean changes in Hb, TSAT, ferritin, and phosphate and AE profiles were similar in the BID and TID regimens as well as in 3 g/day and 4 g/day dosing groups supporting the potential for dosing flexibility with FC. Clinicaltrials.gov identifier NCT03236246 Funding provided by Akebia Therapeutics, Inc.

Ferric Citrate Dosing in Iron Deficiency Anemia in Nondialysis-Dependent Chronic Kidney Disease

2021 ◽  
pp. 1-10
Author(s):  
Pablo E. Pergola ◽  
Diogo Belo ◽  
Paul Crawford ◽  
Moustafa Moustafa ◽  
Wenli Luo ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Ferric Citrate ◽  
Deficiency Anemia ◽  
Open Label ◽  
Starting Dose ◽  
Dosing Regimens

<b><i>Introduction:</i></b> Ferric citrate (FC) is indicated as an oral iron replacement for iron deficiency anemia in adult patients with chronic kidney disease (CKD) not on dialysis. The recommended starting dose is one 1-g tablet three times daily (TID). This study investigated long-term efficacy and safety of different FC dosing regimens for treating anemia in nondialysis-dependent CKD (NDD-CKD). <b><i>Methods:</i></b> In this phase 4, randomized, open-label, multicenter study, patients with anemia with NDD-CKD (estimated glomerular filtration rate, ≥20 mL/min and &#x3c;60 mL/min) were randomized 1:1 to one FC tablet (1-g equivalent to 210 mg ferric iron) TID (3 g/day) or 2 tablets twice daily (BID; 4 g/day). At week 12, dosage was increased to 2 tablets TID (6 g/day) or 3 tablets BID (6 g/day) in patients whose hemoglobin (Hb) levels increased &#x3c;0.5 g/dL or were &#x3c;10 g/dL. Primary endpoint was mean change in Hb from baseline to week 24. <b><i>Results:</i></b> Of 484 patients screened, 206 were randomized and 205 received FC. Mean (standard deviation) changes from baseline in Hb at week 24 were 0.77 (0.84) g/dL with FC TID 3 g/day and 0.70 (0.98) g/dL with FC BID 4 g/day. <b><i>Discussion/Conclusions:</i></b> FC administered BID and TID for 48 weeks was safe and effective for treating anemia in this population, supporting potentially increased dosing flexibility.

scholarly journals MO577EXPANDING THE POTENTIAL BENEFITS OF FERRIC CITRATE FOR IMPROVING IRON-DEFICIENCY ANAEMIA AND MINERAL BONE DISORDER PARAMETERS IN NON-DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE PATIENTS: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Boby Pratama Putra ◽  
Felix Nugraha Putra
Keyword(s):  
Chronic Kidney Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Fibroblast Growth Factors ◽  
Ferric Citrate ◽  
Controlled Trials ◽  
Fibroblast Growth ◽  
Deficiency Anaemia ◽  
Randomized Controlled ◽  
Potential Benefits

Abstract Background and Aims Most of non-dialysis-dependent chronic kidney disease (NDD-CKD) patients will suffer from iron-deficiency anaemia (IDA) also mineral and bone disorders (CKD-MBD) as consequences of CKD progression. Ferric citrate (FC) is an iron-based phosphate binder that based on previous studies showed efficacies in improving IDA and CKD-MBD parameters although the results were still inconclusive. This study aims to establish the overall efficacies of FC in improving IDA and CKD-MBD parameters in NDD-CKD patients. Method We did comprehensive searching using predefined keywords in online databases of Pubmed, EMBASE, ScienceDirect, and The Cochrane Library, to include all relevant studies from 2000-2020. We included all randomized controlled trials (RCTs) accessing the efficacies of FC in improving IDA and CKD-MBD parameters compared with standard care (SC) in NDD-CKD patients. The CKD-MBD parameters analysed in this study are changes in serum phosphorus (P), serum calcium ions (Ca), alkaline phosphatase (ALP), intact fibroblast growth factors-23 (iFGF-23), C-terminal fibroblast growth factors-23 (cFGF-23), and intact parathyroid hormone (iPTH), while the IDA parameters analysed are changes of haemoglobin (Hb), serum iron (Fe), transferrin saturation (TSAT), and ferritin. Bias risk was accessed by using the revised Cochrane Risk-of-bias (RoB-2) tool. Analysis was performed to provide standard mean difference (SMD) with 95% confidence interval (CI) using random-effect heterogeneity test. Results We included six RCTs with total of 1,082 participants met our inclusion criteria. The FC significantly improve CKD-MBD parameters of P (SMD = -0.84. 95% CI = -1.21 to -0.07, p&lt;0.00001, I2 = 74%), iFGF-23 (SMD = -0.43. 95% CI = -0.73 to -0.13, p = 0.005, I2 = 73%), cFGF-23 (SMD = -0.74. 95% CI = -1.12 to -0.35, p = 0.0002, I2 = 78%), and iPTH (SMD = -0.23. 95% CI = -0.40 to -0.06, p = 0.008, I2 = 0%), while the improvement of Ca (SMD = 0.16. 95% CI = -0.07 to 0.38, p = 0.17, I2 = 0%) and ALP (SMD = 0.03. 95% CI = -0.22 to 0.28, p = 0.81, I2 = 14%) are not statistically significant compared with the SC group. The FC also significantly improve IDA parameters of Hb (SMD = 1.10. 95% CI = 0.06 to 2.14, p = 0.04, I2 = 97%), TSAT (SMD = 1.18. 95% CI = 0.67 to 1.69, p&lt;0.00001, I2 = 72%), and ferritin (SMD = 1.10. 95% CI = 0.34 to 1.86, p = 0.004, I2 = 87%) compared with the SC group, unless the improvement of Fe is not statistically significant (SMD = 1.34. 95% CI = -0.28 to 2.95, p = 0.11, I2 = 97%). Conclusion The ferric citrate shows potential benefits for improving iron-deficiency anaemia and CKD-MBD parameters in NDD-CKD patients. Nevertheless, further trials are needed to establish the efficacies.

scholarly journals Prevalence and spectrum of iron deficiency anaemia in heart failure patients

2019 ◽  
Vol 7 (1) ◽  
pp. 132
Author(s):  
Gaurav Mohan ◽  
Gurinder Mohan ◽  
Manish Chandey ◽  
Avneet Kaur ◽  
Trimaan Singh Sikand ◽  
...  
Keyword(s):  
Heart Failure ◽  
Iron Deficiency ◽  
Serum Ferritin ◽  
Iron Deficiency Anaemia ◽  
Large Scale ◽  
Binding Capacity ◽  
Tertiary Care ◽  
Transferrin Saturation ◽  
Care Hospital ◽  
Deficiency Anaemia

Background: To study the prevalence and pattern of iron deficiency (ID)in heart failure (HF) patients with or without anaemia.Methods: This is a single-centre observational study, conducted at a tertiary care hospital of Punjab. Patients were selected based on validated clinical criteria-Framingham criteria. The iron parameters were done during the study including serum iron, serum ferritin, total iron binding capacity, and transferrin saturation (TSAT), to diagnose iron deficiency anaemia. Anaemia was defined as haemoglobin (Hb) < 13g/dl in males and <12 g/dL in females, based on WHO definition. Absolute iron deficiency is defined as serum ferritin < 100 mg/L and functional ID was defined as normal serum ferritin (100–300 mg/L) with low TSAT (<20%).Results: A total of 120 patients of Heart Failure (54% males and 46% females) were studied. Most of the patients were of high-functional NYHA class (Class IV NYHA n=45). Iron Deficiency was present in 60% patients with 31.66% patients having absolute and 28.33% patients having functional ID. Nearly one-fifth of the patients were having ID but without anemia, signifying importance of workup of Iron deficiency other than haemoglobin levels.Conclusions: Study highlights the neglected burden of ID in HF patients in India. This study suggests further large-scale studies to better characterize this easily treatable condition and considering routine testing in future Indian guidelines.

scholarly journals Reducing iron deficiency anaemia due to heavy menstural blood loss in Nigerian rural adolescents. Reprinted from Public Health Nutrition Volume 1 (4), 249–257, 1998

2005 ◽  
Vol 8 (5) ◽  
pp. 451-460
Author(s):  
Fiona Barr ◽  
Loretta Brabin ◽  
Shola Agbaje ◽  
Feikumo Buseri ◽  
John Ikimalo ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Serum Iron ◽  
Iron Deficiency Anaemia ◽  
Iron Status ◽  
Transferrin Saturation ◽  
Cultural Barriers ◽  
Menstrual Disorders ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Deficiency Anaemia

AbstractObjectiveMenstrual disorders are common in young women, and heavy menstrual blood losses (MBL) are an important cause of anaemia. Menstrual morbidity normally goes untreated in developing countries where cultural barriers also serve to make the problems. We investigated the prevelance of menstrual morbidity, and measured MBL and its relationship to iron deficiency in a rural adolescent population. The rationale was to assess whether or not reducing heavy MBL could be part of a strategy to reduce iron deficiency anaemia.SettingRural village in south-east Nigeria.DesignCross-sectional survey.SubjectsThe studdy included all non-pregnant, unmarried nulliparous girls (< 20 years) who had menstruated, and who lived in K'Dere village.MethodsA field worker allocated to each girl completed a questionnaire, and supervised recovery and collection of soiled pads and ensured blood sampling. MBL was measured using the standard alkaline haematin method. Haemoglobin (HB), serum iron, transferin saturation and protoporphyrin levels (ZPP) were also measured.Results307 girls completed MBL measurements; 11.9% refused to participate. 12.1% had menorrhagia (> 80 ml);. median MBL was 33.1 ml. Menorrhagia was more frequent in girls who had menstruated for > 2 years (p = 0.048), and had longer duration of meneses (p < 0.001). Iron status as measured by haematocrit, serum iron, transferrin saturation and ZPP values was inversely related to MBL. Neither height nor body mass index for age was associated with current iron status.ConclusionsThe level of menorrhagia detected (12%) may be an ‘expected’ level for a condition which often has no underlying pathology. Heavy MBL is one of the most important factors contributing to iron deficiency anaemia. Measures are needed to alleviate menstrual disorders and improve iron status. Oral contraceptives can be part of a strategy to reduce anaemia, particularly for adolescents at high risk of unwanted pregnancies.

scholarly journals Efficacy of oral iron therapy in geophagic women with iron deficiency anaemia residing in Botshabelo, South Africa

2020 ◽  
pp. 13-21 ◽  
Author(s):  
LF Mogongoa
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Iron Absorption ◽  
Binding Capacity ◽  
Transferrin Saturation ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anaemia ◽  
Oral Iron Therapy ◽  
Soil Consumption

Background: Iron deficiency anaemia is the most commonly encountered form of anaemia in females worldwide. This form of anaemia is, amongst others, associated with geophagia that is defined as the consumption of soil. The two main reasons for the association of geophagia with anaemia are that soil is thought to supplement mineral deficiency and geophagia is seen as a symptom of the anaemia. However, it is hypothesised that soil consumption interferes with iron absorption instead of supplementing it. The first line of therapy for iron deficiency anaemia is oral iron. Therefore, if soil consumption interferes with iron absorption it could interfere with oral iron therapy leading to patients being burdened with symptoms of anaemia as treatment is not effective. The aim of the study was to evaluate the efficacy of oral iron therapy in female participants afflicted with iron deficiency anaemia associated with geophagia. Methods: In this prospective randomised intervention study, 84 geophagic women with iron deficiency anaemia were divided into two groups. One group continued with soil consumption while the other stopped consumption. Oral iron therapy was administered for ten weeks at increasing therapy doses for both groups. Red cell and iron study parameters were evaluated at different time intervals to ascertain the efficacy of iron replacement therapy. Results: The group that stopped soil consumption showed a statistically significant change in haemoglobin (9.4 to 10.0 g/dL, p = 0.029), mean corpuscular volume (73.6 to 75.7 fl), mean corpuscular haemoglobin (23.7 to 24.6 pg), serum iron (22.5 to 28 μg/dL, p < 0.001, transferrin saturation (4.8 to 6.9%, p < 0.001) and total iron-binding capacity (467 to 441 μg/L, p = 0.001). These findings were contrary to the group that continued with consumption, where the statistical changes were only observed for the iron study parameters (serum iron: 21 to 28 μg/dL, p = 0.038; transferrin saturation: 4.3 to 6.9%, p = 0.011; total iron-binding capacity: 496 to 421 μg/L, p = 0.002). Nevertheless, the changes for both groups were clinically insignificant. Oral iron therapy did not correct the anaemia in geophagic females of both groups, this could be explained by two hypotheses where soil affected the gastrointestinal lining and soil directly interfered with therapy iron absorption. This is evidenced by the group that continued with consumption showing fewer changes than the group that abstained from soil consumption. These results were consistent with a case study where oral iron therapy was implemented. Conclusion: Oral iron therapy was not effective in geophagia cases of iron deficiency anaemia.

scholarly journals New horizons in iron deficiency anaemia in older adults

2020 ◽  
Vol 49 (3) ◽  
pp. 309-318 ◽  
Author(s):  
Jennifer Kirsty Burton ◽  
Luke C Yates ◽  
Lindsay Whyte ◽  
Edward Fitzsimons ◽  
David J Stott
Keyword(s):  
Older Adults ◽  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Adverse Outcomes ◽  
Future Research ◽  
Deficiency Anaemia ◽  
Research Areas ◽  
Dosing Regimens ◽  
Iv Iron

Abstract Iron deficiency anaemia (IDA) is common in older adults and associated with a range of adverse outcomes. Differentiating iron deficiency from other causes of anaemia is important to ensure appropriate investigations and treatment. It is possible to make the diagnosis reliably using simple blood tests. Clinical evaluation and assessment are required to help determine the underlying cause and to initiate appropriate investigations. IDA in men and post-menopausal females is most commonly due to occult gastrointestinal blood loss until proven otherwise, although there is a spectrum of underlying causative pathologies. Investigation decisions should take account of the wishes of the patient and their competing comorbidities, individualising the approach. Management involves supplementation using oral or intravenous (IV) iron then consideration of treatment of the underlying cause of deficiency. Future research areas are outlined including the role of Hepcidin and serum soluble transferrin receptor measurement, quantitative faecal immunochemical testing, alternative dosing regimens and the potential role of IV iron preparations.

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