Clinical trial NCT01677767: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
Official title: Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

Brief summary: This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 to 65 years of age, inclusive
* Patients with chronic kidney disease on dialysis
* ESA naïve with Hb \< 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
* Adequate irons status as judged by the treating physician

Exclusion Criteria:

* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
* Clinically significant concomitant disease or disorder as defined by protocol
* Clinical suspicion of pure red cell aplasia (PRCA)
* Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
* Transfusion of red blood cells in the previous 2 months
* Pregnant women
* Contraindications for Mircera according to local prescribing information or as judged by the investigator

Primary outcomes:
measure: Mean Age of Participants Treated With C.E.R.A
timeFrame: Baseline (Week 0)
measure: Mean Weight of Participants Treated With C.E.R.A
timeFrame: Baseline (Week 0)
measure: Number of Participants With Co-morbidity Treated With C.E.R.A
timeFrame: Up to Week 24
measure: Mean Time Required to Achieve Target Hemoglobin Range
timeFrame: Up to Week 24
measure: Percentage of Participants Achieved Target Range of Hemoglobin
timeFrame: Up to Week 24
measure: Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
timeFrame: Up to Week 24
Secondary outcomes:
measure: Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
timeFrame: Up to Week 24
measure: Mean Time Spent by Participants in the Hb Target Range
timeFrame: Up to Week 24
measure: Evaluation of Route of Administration for C.E.R.A
timeFrame: Up to Week 24
measure: Evaluation of Dose Per Injection of C.E.R.A
timeFrame: Up to Week 24
measure: Number of Participants Received Concomitant Medications
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Gangaram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Ahmedabad Dialysis Centre
city: Guwahati
country: India
facility: Excel Center
city: Kolkata
country: India
facility: ESIS Hospital; Department of Nephrology
city: Mumbai
country: India
facility: Vertex Hospital
city: New Delhi
country: India
facility: Apollo Indraprastha Hospitals; Nephrology
city: Pune
country: India
facility: Aditya Birla Memorial Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: