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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011497-15-IT
Enrollment
Unknown
Registered
2009-04-22
Start date
2009-05-07
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: MIRCERA*IV SC FL 200MCG 1ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Methoxy polyethylene glycol-epoetin beta Concentration unit: µg microgram(s) Concentration type

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026