A Study of All-Cause Mortality and Cardiovascular Morbidity in CKD Patients on Dialysis and Those Not on Renal Replacement Therapy Receiving Mircera or Reference ESAs.

A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference ESAs. - Post Authorization Safety Study (PASS)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005129-31-DE

Enrollment

2800

Registered

2008-08-28

Start date

2008-10-22

Completion date

Unknown

Last updated

2017-10-23

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

Conditions

To gain more experience with MIRCERA administered under clinical practice conditions and according to the approved label by performing a non-inferiority study comparing MIRCERA to other ESAs in terms of cardiovascular morbidity and mortality. MedDRA version: 19.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: MIRCERA® Pharmaceutical Form: Solution for injection INN or Proposed INN: methoxy polyethylene glycol-epoetin beta Current Sponsor code: RO0503821 Concentration unit: µg/ml microgram(s)/mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Adult patients (=18 years old) with symptomatic anaemia associated with CKD (renal anaemia) 3. Patients with renal anaemia who are not treated with an ESA: – Anaemia defined as Hb concentration =65 years) yes F.1.3.1 Number of subjects for this age range 1120

Exclusion criteria

Exclusion criteria: Contraindications to ESA treatment (See Section 4.3 of SmPC): 1. Uncontrolled hypertension 2. Hypersensitivity to the active substance or any of the excipients of MIRCERA® and other ESAs 3. Any other contraindication to ESA therapy Conditions known to cause inadequate response to ESA treatment or anaemia other than symptomatic anaemia associated with CKD, including (See Section 4.4. of the SmPC): 4. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) 5. Anaemia due to hemolysis 6. Pure red cell aplasia (PRCA) Other 7. High likelihood of early withdrawal (e.g. within 1 year) or interruption of the study 8. Pregnancy or breast-feeding 9. Women of childbearing potential without effective contraception 10. Administration of another investigational drug within 1 month before screening or planned during the study period

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction (MI), stroke).;Secondary Objective: To assess the incidence of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA), gastrointestinal bleeding and thromboembolic events.;Primary end point(s): The primary objective is to demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (MI, stroke), based on a non-inferiority limit of 1.20 for the hazard-ratio of the composite endpoint and a one-sided significance level of 0.025. The model used for the non-inferiority analyses will be a Cox model on time to event with treatment as the independent variable but no co-variables included in the model. The analysis will be based on the all-randomized population according to the original treatment assignment. ;Timepoint(s) of evaluation of this end point: Time to composite of all cause mortality and non-fatal cardiovascular events (myocardial infarctions, stroke). [ Time Frame: Event driven ] [ Designated as safety issue: No ]	—

Measure

Time frame

Main Objective: To demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction (MI), stroke).;Secondary Objective: To assess the incidence of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA), gastrointestinal bleeding and thromboembolic events.;Primary end point(s): The primary objective is to demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (MI, stroke), based on a non-inferiority limit of 1.20 for the hazard-ratio of the composite endpoint and a one-sided significance level of 0.025. The model used for the non-inferiority analyses will be a Cox model on time to event with treatment as the independent variable but no co-variables included in the model. The analysis will be based on the all-randomized population according to the original treatment assignment. ;Timepoint(s) of evaluation of this end point: Time to composite of all cause mortality and non-fatal cardiovascular events (myocardial infarctions, stroke). [ Time Frame: Event driven ] [ Designated as safety issue: No ]

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Secondary

Measure	Time frame
Secondary end point(s): Time to the individual components of the composite endpoint: time to death, time to non-fatal cardiovascular events (MI or stroke), time to MI and time to stroke. Incidence of adverse events, and serious adverse events; vital signs, laboratory parameters, ECG. ;Timepoint(s) of evaluation of this end point: Time to the individual components of the composite endpoint: time to death, time to non-fatal cardiovascular events (MI or stroke), time to MI and time to stroke. [ Time Frame: Event driven ] [ Designated as safety issue: No ] Incidence of adverse events, and serious adverse events; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]	—

Measure

Time frame

Secondary end point(s): Time to the individual components of the composite endpoint: time to death, time to non-fatal cardiovascular events (MI or stroke), time to MI and time to stroke. Incidence of adverse events, and serious adverse events; vital signs, laboratory parameters, ECG. ;Timepoint(s) of evaluation of this end point: Time to the individual components of the composite endpoint: time to death, time to non-fatal cardiovascular events (MI or stroke), time to MI and time to stroke. [ Time Frame: Event driven ] [ Designated as safety issue: No ] Incidence of adverse events, and serious adverse events; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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Countries

Argentina, Australia, Belgium, Brazil, Croatia, Czech Republic, France, Germany, Greece, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Panama, Philippines, Poland, Russian Federation, Serbia, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

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