An open-label, multi-center study to demonstrate the efficacy and safety of C.E.R.A when administered intravenously with pre-filled syringes (PFS) for the treatment of anemia in patients with chronic kidney disease who are on dialysis previously receiving subcutaneous or intravenous epoetin alfa or beta or darbepoetin alfa treatment - MIRACE
- Conditions
- MedDRA version: 8.1Level: PTClassification code 10058116Term: Nephrogenic anaemiarenal anemia due to chronic kidney disease
- Registration Number
- EUCTR2006-004032-75-DE
- Lead Sponsor
- Roche Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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 < 4000 or >10000 IU or
weekly iv or sc dosis of darbepoetin alfa < 20 or > 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 < 30 mg/dl (3,54 µmol/l) or other reliable positive test of
hemolysis
9. Active malignant disease (except non-melanoma skin cancer)
10. Vitamin B12 deficiency during screening phase
11. Folic acid deficiency during screening phase
12. Uncontrolled or symptomatic secondary hyperparathyroidism
13. Poorly controlled hypertension (diastolic BP > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>Percentage of patients with or without dose adjustments during evaluation period.<br>
- Secondary Outcome Measures
Name Time Method