A Comparative Review of Erythropoiesis Stimulating Agents

2008 ◽  
Vol 21 (6) ◽  
pp. 424-430
Author(s):  
Nicole L. Metzger ◽  
Kerry E. Francis ◽  
Stacy A. Voils
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Tumor Progression ◽  
Safety And Efficacy ◽  
Regulatory Issues ◽  
Erythropoiesis Stimulating Agents ◽  
Disease States ◽  
Comparative Review ◽  
The Us

Erythropoiesis stimulating agents have been used for more than a decade in patients with chronic kidney disease, malignancy, and other disease states where anemia is common. Recently, several clinical trials have questioned the safety and efficacy of these agents. Thrombosis and increase in tumor progression as well as a potential increase in mortality have been noted in some trials and have generated growing concern regarding whether these agents should remain on the US market. Subsequently, reimbursement from some payers for erythropoiesis stimulating agent administration has become somewhat restrictive. We address the pharmacology, pharmacokinetics, pharmacodynamics, safety, efficacy, and pharmacoeconomics of erythropoiesis stimulating agents as well as emerging regulatory issues pertaining to the administration of erythropoiesis stimulating agents.

scholarly journals Alkali supplementation as a therapeutic in chronic kidney disease: what mediates protection?

2020 ◽  
Vol 319 (6) ◽  
pp. F1090-F1104
Author(s):  
Elinor C. Mannon ◽  
Paul M. O’Connor
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Functional Decline ◽  
Physiological Mechanism ◽  
Basic Research ◽  
Ph Homeostasis ◽  
Disease States ◽  
Kidney Disease Progression ◽  
Acid Base Status

Sodium bicarbonate (NaHCO3) has been recognized as a possible therapy to target chronic kidney disease (CKD) progression. Several small clinical trials have demonstrated that supplementation with NaHCO3 or other alkalizing agents slows renal functional decline in patients with CKD. While the benefits of NaHCO3 treatment have been thought to result from restoring pH homeostasis, a number of studies have now indicated that NaHCO3 or other alkalis may provide benefit regardless of the presence of metabolic acidosis. These data have raised questions as to how NaHCO3 protects the kidneys. To date, the physiological mechanism(s) that mediates the reported protective effect of NaHCO3 in CKD remain unclear. In this review, we first examine the evidence from clinical trials in support of a beneficial effect of NaHCO3 and other alkali in slowing kidney disease progression and their relationship to acid-base status. Then, we discuss the physiological pathways that have been proposed to underlie these renoprotective effects and highlight strengths and weaknesses in the data supporting each pathway. Finally, we discuss how answering key questions regarding the physiological mechanism(s) mediating the beneficial actions of NaHCO3 therapy in CKD is likely to be important in the design of future clinical trials. We conclude that basic research in animal models is likely to be critical in identifying the physiological mechanisms underlying the benefits of NaHCO3 treatment in CKD. Gaining an understanding of these pathways may lead to the improved implementation of NaHCO3 as a therapy in CKD and perhaps other disease states.

Clinical efficacy of immunotherapy for the treatment of solid tumors in patients with chronic kidney disease.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15109-e15109
Author(s):  
Teja Ganta ◽  
Tomi Jun ◽  
Qian Qin ◽  
Vaibhav G. Patel ◽  
Bo Wang ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
T Cells ◽  
Kidney Disease ◽  
Regulatory T Cells ◽  
Solid Tumors ◽  
Smoking Status ◽  
Response To Treatment ◽  
Safety And Efficacy ◽  
Indication For Treatment

e15109 Background: Regulatory T cells play a key role in protecting kidney cells from ischemic injury. Immune checkpoint inhibitors (ICIs) may increase the risk of acute kidney injury via inhibition of regulatory T cells [1, 2]. Prospective clinical trials have largely excluded patients with chronic kidney disease (CKD); thus, we have limited knowledge of the safety and efficacy of ICI in these patients. Herein, we hypothesize that patients with CKD receiving ICIs have worse clinical outcomes. Methods: This single-institution retrospective cohort study included adult patients with solid tumors who were treated with ICIs at The Mount Sinai Hospital between 2011 and 2017. Clinical endpoints [response to treatment, progression of disease (POD) on treatment, mortality] were compared between patients with and without CKD using multivariate logistic regression. Odds ratios were controlled for demographics, primary tumor type, presence of cardiovascular comorbidities, smoking status, incidence of renal adverse events, and a composite of stage of illness with indication for treatment [localized—neoadjuvant, localized—adjuvant, regionally advanced, metastatic disease]. Data were analyzed using R version 3.5.1 with the following packages: readr, dplyr, broom, lubridate, tableone. Results: 420 patients met inclusion criteria: 399 patients without CKD and 21 patients with CKD. Cohorts are well matched for demographics, smoking status, stage/indication for treatment. The CKD cohort has a higher proportion of patients with urothelial cancer compared to patients without CKD (33% vs 11%) as well as a higher proportion of patients with HTN (81% vs 53%), HF (14% vs 3%), and DM (48% vs 21%). There was no statistical difference in odds of response to treatment [OR 0.76, 95% CI 0.26-2.23], POD [OR 0.42, 95% CI 0.15-1.17], or mortality [OR 2.05, 95% CI 0.71-5.96] between the CKD and non-CKD cohort. Conclusions: The data suggest the presence of CKD is not associated with worse clinical outcomes in cancer patients treated with ICIs. As a small retrospective study, the conclusions are hypothesis-generating but support continued use of immunotherapy in CKD in clinical practice and the inclusion of patients with CKD in immunotherapy clinical trials to further clarify safety and efficacy. [Table: see text]

Effect of coronavirus disease in patients with kidney disease in India

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 1255-1259
Author(s):  
Shashi Prabha Singh ◽  
Preeti Sharma ◽  
Durgesh singh ◽  
Pradeep kumar ◽  
Rakesh Sharma ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Meta Analysis ◽  
Tertiary Care ◽  
Type Ii Diabetes Mellitus ◽  
Asymptomatic Infection ◽  
Type Ii ◽  
Cardiorespiratory Failure ◽  
Inflammatory State

Coronavirus disease 19 is a global pandemic which infects over millions of people worldwide in a limited time and changes the lifestyle, clinical spectrum lies from asymptomatic infection to pneumonitis with cardiorespiratory failure and finally death. Higher mortality occurs in senior and who are suffering from co-morbidities like chronic kidney disease, (HTN) hypertension, (DM TYPE II) diabetes mellitus or (CVD) cardiovascular diseases. However, rather than normal individuals, patients with chronic kidney disease (CKD) are under higher risk for infections. The chronic systemic inflammatory state is a significant cause for morbidity and mortality in CKD patients. The objective of this review is to discuss the pathogenesis of COVID-19 in CKD, changes observed in the immune system of CKD patients, COVID-19 infections risk in CKD and therapeutic approach of COVID-19 in CKD patients. From the standpoint of frequent renal co-morbidities in covid19 patients, renal complications were explored in covid19 patients received at level 2 tertiary care Santosh Hospital, Ghaziabad, U.P. Delhi-NCR India during March to August 2020 as per the protocol of Nephrology Society of India. Relevant clinical trials were reviewed in support. Meta-analysis and clinical trials are covered in this review study. Duplicate studies are not taken into account. The outcome of the studies shows that CKD patients are more prone to COVID-19. CKD patients are more likely infected with COVID-19 virus. Whereas in intensive care, CKD occurs more frequent than DM type II and CVD. So,COVID-19 pathogenesis in CKD patients, risk of COVID-19, immunologic changes and therapy COVID-19 in CKD can add support in the effective management of COVID-19.

scholarly journals Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial

2020 ◽  
Vol 36 (1) ◽  
pp. 111-120 ◽  
Author(s):  
Sunil Bhandari ◽  
Philip A Kalra ◽  
Mario Berkowitz ◽  
Diogo Belo ◽  
Lars L Thomsen ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Single Dose ◽  
Kidney Disease ◽  
Iron Deficiency ◽  
Iron Sucrose ◽  
Hypersensitivity Reactions ◽  
Open Label ◽  
Pronounced Increase ◽  
Safety And Efficacy ◽  
Significant Difference

Abstract Background The optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time. The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease and iron deficiency anaemia. Methods In this randomized, open-label and multi-centre trial conducted in the USA, patients were randomized 2:1 to a single dose of 1000 mg IIM or iron sucrose (IS) administered as 200 mg IV injections up to five times within a 2-week period. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to Week 8. Secondary endpoints included incidence of composite cardiovascular adverse events (AEs). Results A total of 1538 patients were enrolled (mean estimated glomerular filtration rate 35.5 mL/min/1.73 m2). The co-primary safety objective was met based on no significant difference in the incidence of serious or severe hypersensitivity reactions in the IIM and IS groups [0.3% versus 0%; risk difference: 0.29% (95% confidence interval: –0.19; 0.77; P > 0.05)]. Incidence of composite cardiovascular AEs was significantly lower in the IIM versus IS group (4.1% versus 6.9%; P = 0.025). Compared with IS, IIM led to a more pronounced increase in Hb during the first 4 weeks (P ≤ 0.021), and change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met. Conclusions Compared with multiple doses of IS, a single dose of IIM induced a non-inferior 8-week haematological response, comparably low rates of hypersensitivity reactions, and a significantly lower incidence of composite cardiovascular AEs.

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