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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660023
• Other study ID #: ML20752
• Secondary ID: 2006-005621-28
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2008
• Last updated: February 16, 2016
• Start date: August 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy, Central Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No