scholarly journals PUK6 - A TARGETED REVIEW OF REAL-WORLD DATA SOURCES IN ANAEMIA OF CHRONIC KIDNEY DISEASE (CKD) IN EUROPE

2018 ◽  
Vol 21 ◽  
pp. S475
Author(s):  
S. Mokiou ◽  
Z. Hakimi ◽  
J. Wang-Silvanto ◽  
S. Horsburgh ◽  
S. Chadda
2019 ◽  
Vol 25 (1) ◽  
pp. 57-59 ◽  
Author(s):  
Stefan Ravizza ◽  
Tony Huschto ◽  
Anja Adamov ◽  
Lars Böhm ◽  
Alexander Büsser ◽  
...  

2019 ◽  
Vol 104 (6) ◽  
pp. e24.1-e24
Author(s):  
P Chanu ◽  
A Weichert ◽  
F Schaefer ◽  
S Meyer Reigner ◽  
B Reigner ◽  
...  

BackgroundC.E.R.A. indicated in Chronic Kidney Disease adult patients to correct and maintain hemoglobin (Hb) levels is approved in Europe and US since 2007; pediatric development is ongoing. A 20-week open-label Phase II study (NH19707) of intravenous (IV) C.E.R.A. in patients aged 5–17 years was conducted and data collected was analysed with adult data1. Objectives were to determine the pharmacokinetic/pharmacodynamic (PK/PD) characteristics of C.E.R.A. in a broad population, to simulate treatment outcomes of C.E.R.A. administered IV and subcutaneous (SC) in pediatric patients and compare them to NH19707 data and Real World Data (RWD).MethodsPK and Hb data from 63 pediatric patients were pooled with 400 adult patients IV and SC data and analysed using models previously developed in adults2. Simulations of treatment outcomes with C.E.R.A. administered IV and SC were performed. Assumptions on SC bioavailability in pediatric patients were based on previous darbepoetin data3. Model inferences were challenged versus RWD obtained in 158 pediatric patients receiving C.E.R.A. SC (N=126) or IV (N=32) from registries maintained by the International Pediatric Dialysis Network (IPDN, www.pedpd.org).ResultsThe adult PK and PK/PD models adequately described the pediatric data and indicated a similar exposure-response relationship in both populations. C.E.R.A. doses were adjusted to Hb levels during the simulation process to reflect clinical practice; simulated Hb levels matched observations. Furthermore, simulated median monthly C.E.R.A. doses following Hb stabilization were 105 µg (95% prediction interval 72–159 µg) for SC and 84 µg (60–123 µg) for IV, in good agreement with those reported in the IPDN registry: 100 µg and 80.4 µg, respectively.ConclusionThe PK/PD characteristics of C.E.R.A. are similar between adult and pediatric populations. Simulations of clinical outcomes in accordance with clinical trial data and RWD provided sufficient clinical evidence to support pediatric plans optimization subsequently approved by FDA and EMA.References1.Fischbach M, Wühl E, Reigner SCM, Morgan Z, Schaefer F. Efficacy and long-term safety of C.E.R.A. maintenance in pediatric hemodialysis patients with anemia of CKD. Clin J Am Soc Nephrol. 2018;13(1):81–90.Chanu P, Gieschke R, Charoin JE, Pannier A, Reigner B. Population pharmacokinetic/pharmacodynamic model for C.E.R.A. in both ESA-naïve and ESA-treated CKD patients with renal anemia. Journal of Clinical Pharmacology. J Clin Pharmacol. 2010;50(5):507–520.3.Amgen Inc. ARANESP® (darbepoetin alfa) prescribing information.Disclosure(s)Chanu P is employee and holds stocks in F Hoffmann-La Roche Ltd, was employee of Certara Consulting Services, Certara, Princeton, NJ, USA and contractor to F Hoffmann-La Roche Ltd at the time of this work. Weichert A is employee of F Hoffmann-La Roche Ltd. Schaefer F has received consulting and speaker honoraria from F Hoffmann-La Roche Ltd. Meyer Reigner S is employee of F Hoffmann-La Roche Ltd. Reigner B is employee and holds stocks in F Hoffmann-La Roche Ltd. Frey N is employee of F Hoffmann-La Roche Ltd.


Author(s):  
Ruth Usó-Talamantes ◽  
Silvia González-de-Julián ◽  
Javier Díaz-Carnicero ◽  
Inmaculada Saurí-Ferrer ◽  
José Luis Trillo-Mata ◽  
...  

This study analyzed the prevalence, costs and economic impact of chronic kidney disease CKD in patients with T2D in a Spanish Health District using real-world data. Observational cross-sectional study in adult patients with T2D was through data extracted from the information systems of the Valencia Clínico–La Malvarrosa Health District in the year 2015. Patients were stratified with the KDIGO classification for CKD. Additionally, patients were assigned to Clinical Risk Groups (CRGs) according to multimorbidity. Direct costs of primary and specialized care, and medication were estimated. The prevalence of T2D in the database population (n = 28,345) was 10.8% (mean age (SD) = 67.8 years (13.9); 51.5% male). Up to 14.935 patients (52.6%) had data on kidney function. According to the KDIGO classification, 66.2% of the patients were at low risk of CKD, 20.6% at moderately increased risk, 7.9% at high risk, and 5.2% at very high risk. The average healthcare costs associated with these four risk groups were EUR 3437, EUR 4936, EUR 5899 and EUR 7389, respectively. The large number of T2D patients with CKD in the early stages of the disease generated a significant increase in direct healthcare costs. The economic impact could be mitigated by early and comprehensive therapeutic approaches.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Juan Jose Garcia Sanchez ◽  
Juan Jesus Carrero ◽  
Supriya Kumar ◽  
Roberto Pecoits-Filho ◽  
Glen James ◽  
...  

Abstract Background and Aims In 2012, the Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommended categorising and prognosticating chronic kidney disease (CKD) based on estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). Contemporary studies describing the prevalence and characteristics of patients with CKD categorised according KDIGO 2012 and how studies of new pharmacotherapies relate to these categories are scarce. One such new therapy class of key interest are the sodium glucose co-transporter 2 inhibitors (SGLT-2i), shown to delay the progression to renal failure and prevent cardiovascular/renal death in patients with CKD. We aimed to describe patient characteristics and the prevalence of CKD according to the 2012 KDIGO categories in a large real-world US cohort of patients with CKD (part A). We also describe a subset of the population according to the DAPA-CKD trial inclusion criteria (eGFR [25-75ml/min/1.73m2] and UACR [200-5000mg/g]) (part B). Method DISCOVER-CKD is an international observational study in patients with CKD. The DISCOVER-CKD retrospective US cohort of patients was extracted using real-world data from the integrated Limited Claims and Electronic Health Record data (IBM Health, Armonk, NY) and HealthVerity. Patients were aged ≥18 years, with ≥1 UACR measure. For part A, required first diagnostic code of CKD (Stages 3A, 3B, 4, 5, or ESRD) or two eGFR of <75 mL/min/1.73 m2 recorded at least 90 days apart and for part B, two measures of eGFR 25-75 mL/min/1.73 m2 recorded at least 90 days apart between 1st January 2008 and September 2018. Index date was diagnostic code or 2nd eGFR. The first UACR, recorded +/-12 months of index, was used to categorise patients. Descriptive analyses were used to summarise prevalence and patient characteristics. Results Of the overall study cohort (N=4330, 49.1% women, mean age 65.3±10.64 years), by KDIGO categories (part A): 85.7% (n=3601) had normal to mildly increased albuminuria, 11.0% (n=463) had moderately increased albuminuria and 3.3% (n=137) had severely increased albuminuria (Figure 1). 4.6% (n=193) fulfilled DAPA-CKD trial inclusion criteria (part B). In both populations, the most common comorbidities were hypertension (HTN, 73.0% for both) and type 2 diabetes (T2D, 57.6% and 56.2%, respectively). Anti-hypertensive drugs were frequently used (76.4% and 76.9%, respectively). Conclusion This study, utilising real-world data, adds to the scarcity of knowledge reporting the characteristics of patients with CKD in different eGFR and UACR strata according to the KDIGO 2012 definitions. We observed a trend in higher UACR in the group of patients with lower eGFR and report a high prevalence of T2D and HTN in the study population, demonstrating the high co-morbidity burden in patients, for whom new therapies may be beneficial.


2015 ◽  
Author(s):  
Martin G. Skjjveland ◽  
Martin Giese ◽  
Dag Hovland ◽  
Espen H. Lian ◽  
Arild Waaler

2015 ◽  
Vol 18 (3) ◽  
pp. A20
Author(s):  
M. Gavaghan ◽  
S. Armstrong ◽  
C. Taggart ◽  
S. Garfield

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