WINE Study: Roxadustat Treatment of Anemia of Chronic Kidney Disease (CKD) in Real-world Clinical Practice - Observational Study Utilizing Routinely Collected Secondary Data from WiNe Registry in Germany

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  To generate real-world evidence that better reflects the actual clinical environment in which roxadustat will be used.
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  EVRENZO
• Name of medicine, other:
  Erythropoiesis-stimulating agents (ESA)
• Study drug International non-proprietary name (INN) or common name:
  DARBEPOETIN ALFA

  EPOETIN BETA

  METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

  ROXADUSTAT
• Anatomical Therapeutic Chemical (ATC) code:
  (B03XA01) erythropoietin

  erythropoietin

  (B03XA02) darbepoetin alfa

  darbepoetin alfa

  (B03XA03) methoxy polyethylene glycol-epoetin beta

  methoxy polyethylene glycol-epoetin beta

  (B03XA05) roxadustat

  roxadustat
• Medical condition to be studied:
  Chronic kidney disease

  Anaemia

Population studied

• Short description of the study population:
  Patients included in this study will be adults with symptomatic anemia of CKD (all stages) requiring treatment with roxadustat or an ESA, irrespective of dialysis status.; ;
• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  180

Study design details

• Study design:
  This is an observational cohort study using routinely collected secondary data of patients with anemia of CKD, newly treated with roxadustat or treated with ESA, identified from the WiNe registry between August 2021 and 6 months before the end of available data.
• Main study objective:
  The primary objectives of this study are to describe the characteristics and comorbidities of patients with CKD newly treated with roxadustat and how these differ when patients are stratified by dialysis status and by prior ESA use. ; In addition, the study will describe the clinical outcomes in patients treated with roxadustat for the management of anemia of CKD, both overall and when stratified by dialysis status and by prior ESA use.;
• Outcomes:
  Primary outcomes include the following:; • Characteristics: Age at index date (defined as the date of the first recorded prescription of either roxadustat or ESA), sex, time since CKD diagnosis, anemia and time since anemia diagnosis, body mass index (BMI), primary cause of CKD, stage of CKD at diagnosis and at index, dialysis status/type of dialysis at index, roxadustat initiation dose at index, inflammatory status, Hb level, iron status (ferritin/serum iron/TSAT/TIBC), PTH levels, renal function (eGFR and albumin/creatinine ratio levels for NDD patients), and use of oral and IV iron treatment at baseline. ; • Comorbidities: e.g., diabetes mellitus, hypertension, congestive heart failure, ischemic heart disease, cerebrovascular disease including stroke, peripheral vascular disease, pulmonary embolism, deep vein thrombosis, vascular access thrombosis, seizures, sepsis, history of cancer/malignancy, chronic inflammatory disease, history of transplants. [The details of reporting of comorbidities will be ascertained at analysis stage]. ; • Medications: RAASi and SGLT2i. ; • Mean dose of roxadustat at initiation, mean dose of roxadustat over time and mean maintenance dose.; • Responsiveness to treatment at specific intervals: time to meet Hb target threshold, proportion of patients achieving Hb target threshold; mean change of Hb, mean change in eGFR and albumin/creatinine ratio levels from baseline for NDD patients; ferritin, TSAT, TIBC, serum iron levels; CRP levels; time to first IV iron treatment from index date; IV iron dose and number of IV iron administrations; time to rescue therapy (ESA); mean PTH levels ;
• Data analysis plan:
  No hypothesis will be tested in this study as it is a descriptive, non-interventional retrospective study. ; Patients will be stratified based on their prescription records during the identification period into 2 exposure groups, roxadustat exposure group or ESA exposure group. ; Data for each exposure group will be summarized to show real-world clinical practices from the WiNe registry.;