MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia

NCT00545571 | Completed Phase 3 Results

• 1 other identifier: ML20826
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 27

Brief Summary

This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent \[ESA\] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter \[g/dL\] for Switzerland and 10 to 12 g/dL for Austria).

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or 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 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. 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 country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) 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.

  At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24

Secondary Outcomes (9)

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

  At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24

• Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)

  Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48

• Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP

  Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24

• Percentage of Hb Values Above or Below the Target Range During the LTSP

  Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48

• Mean Time Spent Above or Below the Target Range for Hb During the LTSP

  Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48

Study Arms (1)

Mircera in Renal Anemia

EXPERIMENTAL

Participants will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.

Drug: Methoxy polyethylene glycol-epoetin beta

Interventions

Methoxy polyethylene glycol-epoetin beta DRUG

Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.

Also known as: 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
• Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
• Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
• Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 months

You may not qualify if:

• Transfusion of red blood cells during previous 2 months
• Significant acute or chronic bleeding, such as overt gastrointestinal bleeding
• Active malignant disease (except non-melanoma skin cancer)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (27)

Unknown Facility

Bregenz, 6900, Austria

Location

Unknown Facility

Feldkirch, 6807, Austria

Location

Unknown Facility

Graz, 8020, Austria

Location

Unknown Facility

Kufstein, 6330, Austria

Location

Unknown Facility

Linz, 4020, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

Unknown Facility

Sankt Pölten, 3100, Austria

Location

Unknown Facility

Steyr, 4400, Austria

Location

Unknown Facility

Vienna, 1030, Austria

Location

Unknown Facility

Vienna, 1100, Austria

Location

Unknown Facility

Vienna, 1130, Austria

Location

Unknown Facility

Vienna, 1160, Austria

Location

Unknown Facility

Vienna, 1220, Austria

Location

Unknown Facility

Basel, 4031, Switzerland

Location

Unknown Facility

Bellinzona, 6500, Switzerland

Location

Unknown Facility

Burgdorf, 3400, Switzerland

Location

Unknown Facility

Geneva, 1205, Switzerland

Location

Unknown Facility

Lausanne, 1011, Switzerland

Location

Unknown Facility

Liestal, 4410, Switzerland

Location

Unknown Facility

Locarno, 6600, Switzerland

Location

Unknown Facility

Lucerne, 6004, Switzerland

Location

Unknown Facility

Lugano, 6903, Switzerland

Location

Unknown Facility

Mendrisio, 6850, Switzerland

Location

Unknown Facility

Sankt Gallen, 9007, Switzerland

Location

Unknown Facility

Sion, 1951, Switzerland

Location

Unknown Facility

Zurich, 8037, Switzerland

Location

Unknown Facility

Zurich, 8091, Switzerland

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

Limitations and Caveats

The Study was prematurely terminated in Austria as a consequence of Mircera reimbursement denial. However, the Study completed regularly in Switzerland and the overall status of the Study is considered completed.

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: October 16, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 24, 2016
• Results First Posted: May 18, 2016

Record last verified: 2016-05

Locations

CH (14); AU (13)