Anaemia in Chronic Kidney Disease (CKD)
Conditions
Interventions
Trade Name: Dynepo
Product Name: DYNEPO
Product Code: SPD490
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Epoetin delta
CAS Number: 261356-80-3
Current Sponsor code: SPD490
Other d
Sponsors
Shire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion, each patient must meet all of the following criteria at Screening, and must continue to fulfil these criteria at Baseline: Aged at least 18 years. Male, or non-pregnant, non-lactating female patients who agree to comply with the contraceptive requirements of the protocol. Patients with CKD (KDOQI stages III–V). Stable on any dose less than or equal to 10,000IU/week of sc EPO or requiring initiation of EPO treatment. Those currently receiving EPO treatment must have been receiving a stable dose, that was effective in managing Hb levels, for at least 30 days immediately prior to randomisation in the study. Those requiring initiation of EPO treatment must have Hb levels of greater than or equal to 8g/dL and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients are excluded from the study if any of the following criteria are met at Screening or at Baseline: Uncontrolled hypertension (defined as a diastolic pressure value >95mmHg, or a systolic value >160mmHg, which remains at that level despite being at dry weight and on more than two medications at maximal dose). Thrombocytopenia (platelet count 3x Upper Limit of Normal [ULN]). Current or recurrent disease that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments. Clinically relevant haematologic, oncologic, cardiovascular, hepatic, neurologic, endocrine, infectious, inflammatory or other major systemic disease making implementation of the protocol or interpretation of the results difficult. Mental condition rendering the patient unable to understand the nature, scope or possible consequences of the study. Patient unlikely to comply with the protocol. Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. Requiring doses of EPO >10,000IU/week. Two or more doses of prescribed EPO treatment missed or withheld by physician order in the 14 days immediately prior to randomisation in the study. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study. Androgen therapy in the 30 days immediately prior to randomisation in the study. Known or suspected intolerance or hypersensitivity to EPO therapy or any of the stated ingredients of Dynepo. Known to have Ab against EPO. Patients with a history of alcohol or other substance abuse within the last year. Treatment with any investigational drug in the 30 days immediately prior to randomisation in the study. Patients that have previously been randomised into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate non-inferiority of efficacy between twice weekly (BIW) and once weekly (QW) dose schedules of Dynepo in previously EPO-naïve patients (pts), measured by Hb at Week 24. Demonstrate non-inferiority of efficacy between QW and once every two weeks (Q2W) dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks (Wks) 16 to 24. ;Secondary Objective: Demonstrate non-inferiority of efficacy between QW & Q2W dose schedules in pts previously stable on EPO, measured by average dose over Wks 16-24. Compare efficacy between BIW & QW in EPO-naïve pts, and between QW & Q2W in pts stable on EPO measured by:a)no.(%) of pts who achieve Hb of >=11g/dL at Wks 16, 24 & over Wks 16-24, b)Hct at Wks 16, 24 & over Wks 16-24, c)no.(%) of pts who achieve the Hct target range of 33%-36% at Wks 16, 24 & over Wks 16-24, d)the no.(%) of pts who achieve both Hb of >=11g/dL & the Hct target range of 33%-36% at Wks 16 & 24 & over Wks 16-24. Compare average dose, over Wks 9-16, 16-24 & 9-24 between dose schedules. Compare efficacy between BIW & QW in EPO-naïve pts, & QW & Q2W measured by Hb at Wk 16 & over Wks 16-24, Hb at Wks 16 & 24 respectively. Investigate safety of BIW & QW in EPO-naïve pts & safety of QW & Q2W in pts stable on EPO. Investigate efficacy and safety switching administration frequencies &, efficacy & safety in pts with DM.;Primary end point(s): Mean Hb concentration calculated at Week 24 and over Weeks 16 to 24. Secondary Endpoints Paitents' average weekly dose/kg over weeks 9 to 16, 16 to 24 and 9 to 24. Number (%) of patients who achieve Hb of equal to or more than 11g/dL at Weeks 16 and 24 and over Weeks 16 to 24. Mean Hct concentration calculated at Weeks 16 and 24 and over Weeks 16 to 24. Number (%) of patients who achieve the Hct target range of 33%-36% at Weeks 16 and 24 and over Weeks 16 to 24. Mean Hb concentration calculated at Week 16. Number (%) of patients who achieve both Hb of equal to or more tha | — |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Latvia, Lithuania, United Kingdom
Outcome results
None listed