A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis

A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Methoxy polyethylene glycol-epoetin beta

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Baja, Hungary, 6500
  • Budapest, Hungary, 1062
  • Debrecen, Hungary, 4032
  • Esztergom, Hungary, 2500
  • Keszthely, Hungary, 8360
  • Miskolc, Hungary, 3526
  • Salgótarján, Hungary, 3100
  • Szolnok, Hungary, 5000
  • VAC, Hungary, 2600
  • Zalaegerszeg, Hungary, 8900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults greater than or equal to (≥) 18 years of age
• Chronic renal anemia
• Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
• Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

Exclusion Criteria:

• Transfusion of red blood cells during previous 2 months
• Poorly controlled hypertension
• Significant acute or chronic bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mircera in Renal Anemia; Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.

Drug: Methoxy polyethylene glycol-epoetin beta; Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.; Other Names: CERA/Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)	Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.	Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Time-Adjusted Hb From Baseline to EEP	Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.	At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP	During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.	Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Mean Time Spent in the Target Range for Hb During the EEP	During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.	Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP	Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.	Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP	Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.	Weeks 0, 4, 8, 12, 16, 20, and 24
Number of Participants Receiving Blood Transfusion During the DTP and EEP	The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.	Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
Number of Blood Transfusions During the DTP and EEP	The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.	Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: April 16, 2008
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (Estimate): April 17, 2008

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML20752; 2006-005621-28