Clinical trial NCT01695746: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia
Official title: Efficacy of Methoxy Poly-Ethylene Glycol Epoetin Beta (C.E.R.A.) for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV, Not 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: 2012-09-28
Enrollment: 108
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 stage III-IV chronic kidney disease not 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 stage III-IV chronic kidney disease patients not 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 stage III-IV chronic kidney disease not on dialysis
* Erythropoiesis stimulating agent (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 iron 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 Height of Participants at Baseline (Week 0)
timeFrame: At Baseline (Week 0)
measure: Mean Weight of Participants at Baseline (Week 0)
timeFrame: At Baseline (Week 0)
measure: Number of Participants With Co-morbidities at Baseline (Week 0)
timeFrame: At Baseline (Week 0)
measure: Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)
timeFrame: Up to Week 24
measure: Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value
timeFrame: Up to Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study
timeFrame: Up to Week 24
measure: Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)
timeFrame: Up to Week 24
measure: Mean Dose of C.E.R.A. Administered
timeFrame: Up to Week 24
measure: Number of Doses of C.E.R.A. Administered by Different Routes
timeFrame: Up to Week 24
measure: Number of Participants Who Received Concomitant Treatment for Anemia
timeFrame: Up to Week 24
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Bhubaneswar
country: India
city: Hyderabad
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: Vadodara
country: India
city: Vellore
country: India
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: