PILOT CLINICAL TRIAL WITH MIRCERA (methoxy polyethylene glycol-epoetin beta) IN DIALYSIS UNIT OF A.O. SAN GIOVANNI BATTISTA DI TORINO - ND

Conditions: End stage renal patients in hemodialysis or peritoneal dialysis treatment
MedDRA version: 9.1Level: LLTClassification code 10014647Term: End stage renal failure

Registration Number: EUCTR2009-011497-15-IT

Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
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

Drug controindications to MIRCERA: ipersensivity reactions to drug formulation or non controlled arterial hypertension
Neoplasia or drug therapy or radioteraphy for previous neoplasia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: 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;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

Secondary Outcome Measures