An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia

NCT01695746 | Completed Results

• 1 other identifier: ML25476
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 6

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (5)

• Mean Height of Participants at Baseline (Week 0)

  The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.

  At Baseline (Week 0)

• Mean Weight of Participants at Baseline (Week 0)

  The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.

  At Baseline (Week 0)

• Number of Participants With Co-morbidities at Baseline (Week 0)

  Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.

  At Baseline (Week 0)

• Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)

  Correction of anemia was evaluated in participants with Hb \< 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.

  Up to Week 24

• Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value

  Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.

  Up to Week 24

Secondary Outcomes (6)

• Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study

  Up to Week 24

• Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)

  Up to Week 24

• Mean Dose of C.E.R.A. Administered

  Up to Week 24

• Number of Doses of C.E.R.A. Administered by Different Routes

  Up to Week 24

• Number of Participants Who Received Concomitant Treatment for Anemia

  Up to Week 24

Study Arms (1)

C.E.R.A.

Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.

Drug: C.E.R.A.

Interventions

C.E.R.A. DRUG

Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.

C.E.R.A.

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 stage III-IV chronic kidney disease not 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 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

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 (6)

Unknown Facility

Bhubaneswar, 751021, India

Location

Unknown Facility

Hyderabad, 500 029, India

Location

Unknown Facility

Mumbai, 400012, India

Location

Unknown Facility

Mumbai, 400036, India

Location

Unknown Facility

Vadodara, 390005, India

Location

Unknown Facility

Vellore, 632006, 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 61 6878333

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: September 27, 2012
• First Posted: September 28, 2012
• Study Start: August 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 2, 2016
• Results First Posted: June 2, 2016

Record last verified: 2016-04

Locations

IN (6)