An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677767
• Other study ID #: ML25475
• Status: Completed
• Phase: N/A
• First received: August 30, 2012
• Last updated: February 8, 2016
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drug Controller General
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Age of Participants Treated With C.E.R.A	Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25	Baseline (Week 0)	No
Primary	Mean Weight of Participants Treated With C.E.R.A	Weight of the participants was measured at the Baseline and summarized with descriptive statistics.	Baseline (Week 0)	No
Primary	Number of Participants With Co-morbidity Treated With C.E.R.A	Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.	Up to Week 24	No
Primary	Mean Time Required to Achieve Target Hemoglobin Range	The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1	Up to Week 24	No
Primary	Percentage of Participants Achieved Target Range of Hemoglobin	The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.	Up to Week 24	No
Primary	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.	Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.	Up to Week 24	No
Secondary	Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study	For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.	Up to Week 24	No
Secondary	Mean Time Spent by Participants in the Hb Target Range	Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.	Up to Week 24	No
Secondary	Evaluation of Route of Administration for C.E.R.A	C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.	Up to Week 24	No
Secondary	Evaluation of Dose Per Injection of C.E.R.A	The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.	Up to Week 24	No
Secondary	Number of Participants Received Concomitant Medications	Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.	Up to Week 24	No