E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
End stage renal patients in hemodialysis or peritoneal dialysis treatment |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014647 |
E.1.2 | Term | End stage renal failure |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
noninferiority and safety evaluation of MIRCERA versus conventional epoetin theapy in hemodiaysis and peritoneal dialysis population in Dialysis Unit of A.O. San Giovanni Battista di Torino |
|
E.2.2 | Secondary objectives of the trial |
evaluation of hemoglobin values stability, reticolocytes values stability, sideremia and vitamin status stability and number of therapy modification before and after shift from conventional epoetin therapy to MIRCERA |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
no evidence of clinical problems with influence on blood crasis (i.e. Infections, bleedings, surgical procedures) in the last 6 months - stable hemoglobin values into NKF-DOKI range (11-12g/dl) or more for minimum three months before study inclusion epoetin alfa, epoetin beta, darbopoetin therapy with modifications inferior to 25% of the dose for minimum three months before study inclusion therapy with ferrum or B12 vitamin or folinic acid administration without any modification for minimum three months before study inclusion last available PTHi value < 500pg/ml |
|
E.4 | Principal exclusion criteria |
Drug controindications to MIRCERA: ipersensivity reactions to drug formulation or non controlled arterial hypertension Neoplasia or drug therapy or radioteraphy for previous neoplasia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
noninferiority and safety evaluation of MIRCERA versus conventional epoetin theapy in hemodiaysis and peritoneal dialysis population in Dialysis Unit of A.O. San Giovanni Battista di Torino |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |