renal anemia due to chronic kidney disease MedDRA version: 8.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia
Conditions
Interventions
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegserepoeitin alfa
Current Sponsor code: RO0503821
Concentration unit: µg microgram(s)
Concentration type: equ
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Adult patients (18 years and older) with chronic renal anemia 3. Regular long-term hemodialysis with the same mode of dialysis for at least 12 weeks before screening phase 4. Kt/V 1.2 or greater or urea reduction of > 65% 5. Baseline hemoglobin concentration between 10 and 13 g/dl 6. Weekly iv or sc dosis of epoetin alfa, beta or delta 4000 – 10000 IU or weekly iv or sc dosis of darbepoetin alfa 20 – 50 µg (or of darbepoetin alfa is used in longer intervals a dosing matching the given weekly dose) 7. Intravenous or subcutaneous maintenance epoetin alfa, beta or delta or darbepoetin alfa therapy with the same dosing interval (i.e., one, two or three times weekly or every second week) for at least 4 weeks before the screening phase. 8. Adequate iron status defined as serum ferritin 100 ng/mL or more or TSAT within Lab normal values within 4 weeks prior to study start and confirmed during screening pahse. 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: 1. Relevant acute or chronic bleeding i.e. requiring therapy within 8 weeks prior to screening e.g. overt gastrointestinal bleeding 2. RBC transfusions within 8 weeks before screening phase 3. Patients who are on dialysis due to graft failure unless the graft is removed 4. Change in hemoglobin concentration = 2 g/dl during the 2 months screening period or hemoglobin out of range (10-13 g/dl) during screening phase if confirmed within 2 weeks 5. Weekly iv or sc dosis of epoetin alfa, beta or delta 10000 IU or weekly iv or sc dosis of darbepoetin alfa 50 µg at study start or respective dose if not administered weekly 6. Change in frequency, route of administration or medication in therapy with epoetin alfa, beta or delta or darbepoetin alfa, respectively, during the screening phase. 7. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) 8. Hemolysis haptoglobin 100) or interruption of epoetin alfa, beta or delta or darbepoetin alfa treatment due to high BP in the 6 months before screening phase 14. Epileptic seizure in the 6 months before screening-phase 15. acute or chronic systemic inflammatory disease 16. Myocardial infarction or stroke within 12 weeks before screening. 17. Severe or unstable coronary artery disease 18. Severe liver disease 19. Platelets > 500 x 10 9/L or < 100 x 10 9 /l at the beginning of screening phase 20. Confirmed Pure red cell aplasia (PRCA) or suspected PRCA 21. Chronic congestive heart failure (New York Heart Association Class IV) 22. Planned elective surgery during the study period except for cataract surgery 23. Life expectancy less than 12 months 24. Pregnancy or lactation period 25. Women of childbearing potential without effective method of contraception (effective means less than 1% failure rate per year) 26. Previous treatment with C.E.R.A 27. Administration of another investigational drug within 4 weeks or 7 half-lifes of the IMP, whatever longer, before start of study 28. Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study drug formulations 29. Temporary dialysis access catheter (e.g. Shaldon Catheter) 30. Underage Patients or patients who are not able to understand the meaning of this clinical trial (according to §40 Abs. 4 and §41 Abs. 2 and Abs. 3 AMG) 31. Patients who have been enrolled in this trial before 32. Known psychological disease, which can inhibit the patient to fully understand the meaning of the study 33. Persons who are possibly dependent from sponsor and/or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the intravenous once monthly administration of C.E.R.A with pre-filled syringes achieves stable hemoglobin concentrations in dialysis patients on prior intravenous or subcutaneous epoetin alfa or beta or darbepoetin alfa of chronic renal anemia;Secondary Objective: To assess the safety and tolerability of intravenous administration of C.E.R.A with prefilled syringes in this patient population;Primary end point(s): Percentage of patients in a defined Hb-corridor (11-12.5 g/dl or 10-13 g/dl) during evaluation period. Percentage of patients with or without dose adjustments during evaluation period. | — |
Countries
Germany
Outcome results
None listed