Anaemia in Chronic Kidney Disease (CKD)
Conditions
Interventions
Trade Name: Dynepo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Epoetin delta
CAS Number: 261356-80-3
Current Sponsor code: SPD490
Other descriptive name: Epoetin delta
Concentrati
Sponsors
Shire Pharmaceutical Contracts Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who complete Dynepo study SPD490-301. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of >=10g/dL between Weeks 16 and 24 of study SPD490-301. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Withdrawal, before Week 24, from SPD490-301. Pregnant or lactating women. Uncontrolled hypertension. Thrombocytopenia (platelet count <75,000/mm3). Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding). Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study. Androgen therapy in the 30 days immediately prior to enrolment in this study. Known Human Immunodeficiency Virus (HIV) infection. History of hypersensitivity to Dynepo. Known to have Ab against EPO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.;Secondary Objective: Assess long-term safety, as measured by safety parameters other than reported Adverse Events (AEs), but including antibody (Ab) responses to Dynepo. Assess maintenance of efficacy in long-term usage of Dynepo. Summarise differences in dose requirements according to dialysis status. Compare dose requirements between dose schedules. Summarise efficacy and safety in patients with diabetes mellitus (DM). Evaluate changes in diabetic retinopathy.;Primary end point(s): Primary Endpoint: Rate of emergence of TEAEs over the course of the study. Secondary Endpoint: Number (%) of patients developing neutralising Ab and a positive Ab response to EPO. Changes in haematology and biochemistry parameters from Baseline of study SPD490-402. Blood pressure changes from Baseline of study SPD490-402. Hb and Hct calculated over the course of the study. Changes in Left Ventricular Ejection Fraction (LVEF) from the Screening visit of study SPD490-402. Renal function using estimated Glomerular Filtration Rate (eGFR). Withdrawal rates, by reason for withdrawal, over the course of the study. Patients’ average weekly dose/kg over the course of the study, grouped by dialysis status. Differences in patients’ average weekly dose over the course of the study, by dosing schedule, matched for dialysis status and eGFR. Changes in retinal photographs for those diabetic patients who had photographs taken at Screening of study SPD490-301, based on a predefined rating system for diabetic retinopathy. Changes in haematology and biochemistry parameters, LVEF and other measures from Baseline of study SPD490-301. | — |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Latvia, Spain, United Kingdom
Outcome results
None listed