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

NCT00660023 | Completed Phase 3 Results

• 2 other identifiers: ML207522006-005621-28
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean Change in Time-Adjusted Hb From Baseline to EEP

  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

  Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

• Mean Time Spent in the Target Range for Hb During the EEP

  Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

• Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP

  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

  Weeks 0, 4, 8, 12, 16, 20, and 24

Study Arms (1)

Mircera in Renal Anemia

EXPERIMENTAL

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

Interventions

Methoxy polyethylene glycol-epoetin beta DRUG

Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.

Also known as: CERA/Mircera

Mircera in Renal Anemia

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Unknown Facility

Baja, 6500, Hungary

Location

Unknown Facility

Budapest, 1062, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Esztergom, 2500, Hungary

Location

Unknown Facility

Keszthely, 8360, Hungary

Location

Unknown Facility

Miskolc, 3526, Hungary

Location

Unknown Facility

Salgótarján, 3100, Hungary

Location

Unknown Facility

Szolnok, 5000, Hungary

Location

Unknown Facility

Vác, 2600, Hungary

Location

Unknown Facility

Zalaegerszeg, 8900, Hungary

Location

Related Publications (1)

• 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.

  PMID: 26965694 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

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: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 17, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 15, 2016
• Results First Posted: March 15, 2016

Record last verified: 2016-02

Locations

HU (10)