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

NCT01677767 | Completed Results

• 1 other identifier: ML25475
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 7

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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

• 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

• 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

• 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

Secondary Outcomes (5)

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

  Up to Week 24

• Mean Time Spent by Participants in the Hb Target Range

  Up to Week 24

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

  Up to Week 24

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

  Up to Week 24

• Number of Participants Received Concomitant Medications

  Up to Week 24

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Sir Gangaram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Ahmedabad Dialysis Centre

Ahmedabad, 380005, India

Location

Excel Center

Guwahati, 781007, India

Location

ESIS Hospital; Department of Nephrology

Kolkata, 600054, India

Location

Vertex Hospital

Mumbai, 400083, India

Location

Apollo Indraprastha Hospitals; Nephrology

New Delhi, 110076, India

Location

Aditya Birla Memorial Hospital

Pune, 411033, India

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: April 30, 2011
• Primary Completion: September 30, 2013
• Study Completion: September 30, 2013
• Last Updated: July 5, 2017
• Results First Posted: February 5, 2016

Record last verified: 2017-05

Locations

IN (7)