Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

Preeclampsia and the Ten-Year Risk of Incident Chronic Kidney Disease

2020 ◽  
Vol 10 (3) ◽  
pp. 188-197
Author(s):  
Samira Behboudi-Gandevani ◽  
Mina Amiri ◽  
Maryam Rahmati ◽  
Saber Amanollahi Soudmand ◽  
Fereidoun Azizi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Chronic Kidney Disease ◽  
Logistic Regression ◽  
Kidney Disease ◽  
Population Based ◽  
Incidence Rates ◽  
Prior History ◽  
P Value

Background: Although preeclampsia (PE), as an endothelial disorder can lead to renal dysfunction during pregnancy, results of studies focusing on the potential long-term potential effects of PE on renal function are insufficient and those available are controversial. This study investigated the incidence rate and risk of chronic kidney disease (CKD) among women with prior history of PE compared with healthy controls in a long-term population-based study. Methods: This was a prospective population-based cohort study. Subjects were 1,851 eligible women, aged 20–50 years, with at least 1 pregnancy (177 women with prior-PE and 1,674 non-PE controls) selected from among the Tehran-Lipid and Glucose-Study-participants. A pooled-logistic-regression-model and Cox’s-proportional-hazards-models were utilized to estimate the risk of CKD in women of both PE and without PE groups, after further adjustment for confounders. Results: Median and interquartile ranges for follow-up durations of the PE and non-PE groups were 7.78 (5.19–10.40) and 7.32 (4.73–11.00) years, respectively. Total cumulative incidence rates of CKD at the median follow-up time of each group were 35/100,000 (95% CI 25/100,000–50/100,000) and 36/100,000 (95% CI 32/100,000–39/100,000) in PE and non-PE women, respectively (p value = 0.90). Based on pooled-logistic-regression-analysis, OR of CKD progression (adjusted for age, body mass index [BMI], systolic blood pressure [SBP], and diastolic blood pressure [DBP]) for the PE group did not differ, compared to their non-PE counterparts (OR 1.04; p value = 0.80; 95% CI 0.77–1.40). Compared to non-PE women, women with prior PE did not have higher hazard ratios (HRs) of developing CKD in the unadjusted model (unadjusted HR 1.1, 95% CI 0.83–1.69, p = 0.35), results which remained unchanged after adjustment for age, BMI, baseline SBP, and DBP. Conclusion: PE was not found to be a risk factor for CKD. More studies using a prospective cohort design with long-term follow-ups are needed to investigate the relationship between preeclamsia and CKD.

scholarly journals Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Phase IV Post-Authorization Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Renal Failure ◽  
Chronic Renal Failure ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
Treatment Phase ◽  
Enzyme Linked Immunosorbent Assay ◽  
P Value ◽  
End Of Treatment ◽  
Phase Iv

Abstract Background This phase IV, post–authorisation safety & efficacy study evaluated the safety, immunogenicity and tolerability of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) for the treatment of symptomatic anemia in Indian patients with chronic renal failure.Methods Adults patients of either gender suffering from anemia associated with chronic renal failure patients were prescribed and treated with DA-α and followed up for 1 year. 503 patients were enrolled into the study, of which 121 patients were evaluated for immunogenicity at the end of treatment phase (up to 24 weeks) and after 1-year (52 weeks after start of treatment) follow up. Safety end points were the incidence of treatment emergent adverse events (TEAEs) and immunogenicity as assessed by anti-drug antibody titers using validated enzyme linked immunosorbent assay (ELISA) methods. Efficacy end point included improvement in the hemoglobin, mean change in Hemoglobin (Hb) levels from baseline to end of treatment (up to 24 weeks). Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

scholarly journals Insulinoma and Chronic Kidney Disease: An Uncommon Conundrum Not to Be Overlooked

2017 ◽  
Vol 10 ◽  
pp. 117955141774262 ◽  
Author(s):  
Luca Foppiani ◽  
Serena Panarello ◽  
Marco Filauro ◽  
Maria Concetta Scirocco ◽  
Stefano Cappato ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Pancreatic Head ◽  
Small Region ◽  
Uncinate Process ◽  
Positron Emission ◽  
Long Term Follow Up ◽  
Histology And Immunohistochemistry

A hypertensive man with chronic kidney disease (CKD) secondary to polycystic disease was hospitalized for symptoms related to hypoglycemia. Fasting test elicited symptomatic hypoglycemia after 12 hours, which was associated with inappropriately unsuppressed normal insulin and C-peptide levels. Neither ultrasonography (US) nor magnetic resonance imaging detected any pancreatic tumor. Endoscopic ultrasonography (EUS) showed a small isoechogenic nodule suspect for neuroendocrine tumor in the pancreatic head. 68Gallium-DOTA-Tyr3-octreotide positron emission tomography/computed tomography revealed intense uptake by a small region in the pancreatic head. Surgical exploration together with intraoperative US confirmed the nodule in the pancreatic head and evidenced another hypoechogenic one in the uncinate process. Both nodules were enucleated, but only the latter, which had not been previously detected by EUS, proved compatible with insulinoma on combined histology and immunohistochemistry. After nodule enucleation, hypoglycemia resolved and did not relapse. Insulinoma, as a major cause of unexplained hypoglycemia, requires careful hormonal and instrumental workup. In patients with CKD, the interpretation of biochemical criteria for the diagnosis of insulinoma can be challenging. Localization techniques may display pitfalls. Surgery is curative in most patients but long-term follow-up is required.

scholarly journals MP31-19 LONG-TERM FOLLOW-UP OF RENAL FUNCTION AND DEVELOPMENT OF CHRONIC KIDNEY DISEASE AFTER PARTIAL NEPHRECTOMY

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Takashi Ikeda* ◽  
Toshio Takagi ◽  
Hiroki Ishihara ◽  
Hironori Fukuda ◽  
Kazuhiko Yoshida ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Renal Function ◽  
Kidney Disease ◽  
Partial Nephrectomy ◽  
Long Term Follow Up

Abstract 15407: Comorbidities and the Associated Long-term Utilization of Transthoracic Echocardiography Among Medicare Beneficiaries at a Large Academic Center

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Patrick M Hyland ◽  
Jiaman Xu ◽  
Changyu Shen ◽  
Lawrence Markson ◽  
Warren J Manning ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Transthoracic Echocardiography ◽  
Medicare Beneficiaries ◽  
Female Sex ◽  
History Of

Introduction: The association between baseline patient characteristics and the long-term utilization of transthoracic echocardiography (TTE) is unknown and may help focus value-based care initiatives. Methods: TTE reports from patients with ≥ 2 TTEs at our institution were linked to 100% Medicare Fee-for-service inpatient claims, 1/1/2000 – 12/31/2017. To avoid inclusion of individuals with short-interval follow-up, TTEs with < 1 year between studies were excluded. Validated claims algorithms were used to create 12 baseline cardiovascular comorbidities. Multivariable Poisson regression was used to estimate adjusted rates of TTE intensity according to baseline comorbidities. Results: Over a median (IQR) follow-up of 5.8 (3.1 – 9.5) years, 18,579 individuals (69.3 ± 12.8 years; 50.5% female) underwent a total of 59,759 TTEs (range 2 – 59). The median TTE intensity was 0.64 TTEs/patient/year (IQR 0.35 – 1.24; range 0.11 – 22.02). The top five contributors to TTE intensity were heart failure, chronic kidney disease, history of myocardial infarction, smoking, and hyperlipidemia ( Figure ). Female sex was associated with decreased TTE utilization (adjusted RR 0.95, 95% CI 0.94-0.96, p < 0.0001). Atrial fibrillation, hypertension, and history of ischemic stroke or transient ischemic attack were not significantly related to TTE intensity after multivariable adjustment (all p > 0.05). Conclusions: Among Medicare beneficiaries with ≥ 2 TTEs at our institution, the median TTE intensity was 0.64 TTEs/patient/year but varied widely. Heart failure, chronic kidney disease, and history of myocardial infarction were the strongest predictors of increased utilization. Female sex was associated with decreased utilization, reflecting broader disparities in utilization of cardiovascular procedures. Further research is needed to clarify reasons for this sex disparity and associations with cardiovascular outcomes.

66 Renal long-term follow up after pregnancy and risk of chronic kidney disease

2016 ◽  
Vol 6 (3) ◽  
pp. 210
Author(s):  
Thais Alquezar Facca ◽  
Amelia Rodrigues Pereira ◽  
Michele Tiveron Passos ◽  
Larissa Fatima Santos ◽  
Eduardo Brosco Fama ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Long Term Follow Up
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