Late-Stage Development

Aug 19, 2024 | bpspubs.onlinelibrary.wiley.com | Hongtao Yu |Peter J. Greasley |Philip Ambery |Late-Stage Development

CKDCalbumin plasma albumin concentration CD collecting duct CKD chronic kidney disease CO cardiac output CVP central venous pressure ECE endothelin converting enzyme eGFR estimated glomerular filtration rate GFR glomerular filtration rate GPinjury glomerular injury signal IFV interstitial fluid volume Kalbumin glomerular albumin sieving coefficient Km, gp, siev glomerular injury signal that produces half the maximum rise in the sieving coefficient MAP mean arterial pressure N number of...

Jan 27, 2024 | link.springer.com | Inner Mongolia |Late-Stage Development

AbstractAnemia of chronic kidney disease (CKD) has a high incidence and is associated with many disease conditions. Iron dysmetabolism is an important contributor to anemia in CKD patients. ALTAI, a randomized, active-controlled, phase 4 trial, investigated the efficacy of roxadustat versus recombinant human erythropoietin (rHuEPO) on gastrointestinal iron absorption in patients with anemia of CKD (stage 4/5).

Sep 19, 2023 | link.springer.com | Harefield Hospitals |Late-Stage Development

AbstractSevere asthma is associated with airway inflammation and airway obstruction. In the phase 3 NAVIGATOR study, tezepelumab treatment significantly improved pre-bronchodilator forced expiratory volume in 1 s (FEV1) compared with placebo in patients with severe, uncontrolled asthma. This analysis assessed the effect of tezepelumab versus placebo on additional lung function parameters in patients from NAVIGATOR. NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study.

Sep 12, 2023 | link.springer.com | Late-Stage Development

AbstractPatients with uncontrolled, allergic severe asthma may be prescribed biologic therapies to reduce exacerbations and improve disease control. Randomized controlled trials (RCTs) of these therapies have differed in design, with varying results overall and by baseline blood eosinophil count (BEC). This study describes published annualized asthma exacerbation rate (AAER) reductions from RCTs in patients with allergic severe asthma, overall and by baseline BEC category.