Phase II trials in drug development and adaptive trial design
GA Van Norman - JACC: Basic to Translational Science, 2019 - jacc.org
… which has now established means by which to qualify biomarkers for use in drug development,
but there is a lack of validated biomarkers at this time (14–16). Commercial development …
but there is a lack of validated biomarkers at this time (14–16). Commercial development …
Pre-trial qualitative work with health care professionals to refine the design and delivery of a randomised controlled trial on kidney care
S Husbands, F Caskey, H Winton, A Gibson… - Trials, 2019 - Springer
… Patients eligible for inclusion in PrepareME needed to have existing or newly diagnosed
stage 5 chronic kidney disease (CKD… The CI and TMG decided to reconsider the name of the …
stage 5 chronic kidney disease (CKD… The CI and TMG decided to reconsider the name of the …
Opioids for chronic pain management in patients with dialysis-dependent kidney failure
DG Tobin, MB Lockwood, PL Kimmel… - Nature Reviews …, 2022 - nature.com
… Coma and apnoea occur in the final phases of an overdose … therapy and frequently reassess
appropriateness and safety. … state or provincial regulatory requirements before writing the …
appropriateness and safety. … state or provincial regulatory requirements before writing the …
Ethics of kidney care in the era of COVID-19
… -stage organ failure, dialysis is used in the chronic treatment of >2 million people worldwide.
… interventions without the oversight and patient protections normally afforded in clinical trials. …
… interventions without the oversight and patient protections normally afforded in clinical trials. …
Systematic review of the role of cytoreductive nephrectomy in the targeted therapy era and beyond: an individualized approach to metastatic renal cell carcinoma
B Bhindi, EJ Abel, L Albiges, K Bensalah, SA Boorjian… - European urology, 2019 - Elsevier
… We reviewed studies reporting on patients diagnosed with RCC that was metastatic at … at
least an intermediate risk, and did not enroll patients who were eligible for upfront surveillance …
least an intermediate risk, and did not enroll patients who were eligible for upfront surveillance …
Dialysis for older adults: why should the targets be different?
P Khatri, A Davenport - Journal of Nephrology, 2024 - Springer
… The demographics of the end-stage kidney disease (ESKD) … , large prospective trials focusing
on elderly patients are … considered based on metabolic requirements, volume status and …
on elderly patients are … considered based on metabolic requirements, volume status and …
[HTML][HTML] Roxadustat for anemia in patients with kidney disease not receiving dialysis
N Chen, C Hao, X Peng, H Lin, A Yin… - … England Journal of …, 2019 - Mass Medical Soc
… Eligible patients were between the ages of 18 and 75 years, had chronic kidney disease of
stage 3 … This factor may indicate the need to reconsider the threshold of iron measures below …
stage 3 … This factor may indicate the need to reconsider the threshold of iron measures below …
Generalisability of common oncology clinical trial eligibility criteria in the real world
S Karim, Y Xu, S Kong, O Abdel-Rahman, ML Quan… - Clinical Oncology, 2019 - Elsevier
… characterise the potential eligibility of real-world patients for oncology clinical trials. We …
eligibility criteria from practice changing phase III clinical trials to a cohort of 379 registry patients …
eligibility criteria from practice changing phase III clinical trials to a cohort of 379 registry patients …
Evolving strategies in the treatment of anaemia in chronic kidney disease: the HIF-prolyl hydroxylase inhibitors
F Locatelli, R Minutolo, L De Nicola, L Del Vecchio - Drugs, 2022 - Springer
… and heart failure and contributes to the progression of renal disease to end-stage renal disease
(ESRD)… These trials led to a rethinking of the ‘Hb target’ to aim at with ESA, and to a more …
(ESRD)… These trials led to a rethinking of the ‘Hb target’ to aim at with ESA, and to a more …
Decongestion in Acute Heart Failure—Time to Rethink and Standardize Current Clinical Practice?
V Bilgeri, P Spitaler, C Puelacher, M Messner… - Journal of Clinical …, 2024 - mdpi.com
… of preexisting/worsening renal dysfunction but should be used … in the early phase of myocardial
dysfunction with increased … dose requirements tend to increase over time in HF patients, …
dysfunction with increased … dose requirements tend to increase over time in HF patients, …