Skip to main content
OpenTrials
Completed

NCT Number: NCT01677767

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sir Gangaram Hospital, New Delhi, National Capital Territory of Delhi, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mean Age of Participants Treated With C.E.R.A

    Time frame: Baseline (Week 0)

    Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25

  2. Mean Weight of Participants Treated With C.E.R.A

    Time frame: Baseline (Week 0)

    Weight of the participants was measured at the Baseline and summarized with descriptive statistics.

  3. Number of Participants With Co-morbidity Treated With C.E.R.A

    Time frame: Up to Week 24

    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.

  4. Mean Time Required to Achieve Target Hemoglobin Range

    Time frame: Up to Week 24

    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

  5. Percentage of Participants Achieved Target Range of Hemoglobin

    Time frame: Up to Week 24

    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.

  6. 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.

    Time frame: Up to Week 24

    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.

Secondary outcomes

  1. Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study

    Time frame: Up to Week 24

    For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.

  2. Mean Time Spent by Participants in the Hb Target Range

    Time frame: Up to Week 24

    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.

  3. Evaluation of Route of Administration for C.E.R.A

    Time frame: Up to Week 24

    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.

  4. Evaluation of Dose Per Injection of C.E.R.A

    Time frame: Up to Week 24

    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.

  5. Number of Participants Received Concomitant Medications

    Time frame: Up to Week 24

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 3, 2012
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.