A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis

NCT00559637 | Completed Phase 3 Results

• 2 other identifiers: ML208882007-000126-46
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 50

Brief Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.

Conditions

Anemia

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)

  Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.

  Evaluation phase (Months 8 and 9)

• Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL

  Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.

  Evaluation phase (Months 8 and 9)

• Change From Baseline in Hemoglobin Value to the Evaluation Phase

  The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.

  Baseline, evaluation phase (Months 8 and 9)

Secondary Outcomes (5)

• Duration of Hemoglobin Values in the Range of 11-12 g/dL

  Baseline to Month 9

• Duration of Hemoglobin Values in the Range of 11-13 g/dL

  Baseline to Month 9

• Time to Increase of Hemoglobin Value to Over 11 g/dL

  Baseline to Month 9

• Total Number of Dose Adjustments

  Baseline until Month 8

• Total Number of Red Blood Cell (RBC) Transfusions

  Baseline to Month 9

Study Arms (1)

Methoxy polyethylene glycol-epoetin beta

EXPERIMENTAL

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.

Drug: Methoxy polyethylene glycol-epoetin beta

Interventions

Methoxy polyethylene glycol-epoetin beta DRUG

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.

Also known as: Mircera

Methoxy polyethylene glycol-epoetin beta

Eligibility Criteria

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

You may qualify if:

• chronic renal anemia;
• hemoglobin value less than or equal to (\<=) 10.5 grams/deciliter (g/dL).

You may not qualify if:

• prior ESA therapy during previous 3 months;
• acute or chronic bleeding requiring therapy during previous 2 months;
• transfusion of red blood cells during previous 2 months;
• active malignant disease (except non-melanoma skin cancer).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (50)

Unknown Facility

Ansbach, 91522, Germany

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Arnsberg, 59759, Germany

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Bad Aibling, 83043, Germany

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Berlin, 10115, Germany

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Bischofswerda, 01877, Germany

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Bonn, 53179, Germany

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Cologne, 50937, Germany

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Cologne, 51109, Germany

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Dieburg, 64807, Germany

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Dortmund, 44135, Germany

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Düsseldorf, 40211, Germany

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Emsdetten, 48282, Germany

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Frankfurt, 60528, Germany

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Friedberg, 86316, Germany

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Grimma, 04668, Germany

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Hamburg, 21073, Germany

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Hamburg, 22391, Germany

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Heidelberg, 69120, Germany

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Hilden, 40721, Germany

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Homburg, 66424, Germany

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Hoyerswerda, 02977, Germany

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Jena, 07743, Germany

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Kaiserslautern, 67655, Germany

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Loerrach, 79539, Germany

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Ludwigslust, 19288, Germany

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Lübeck, 23562, Germany

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Lünen, 44534, Germany

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Mainz, 55131, Germany

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Malente, 23714, Germany

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Mettmann, 40822, Germany

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Mühlacker, 75417, Germany

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München, 81545, Germany

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Regensburg, 93053, Germany

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Rheine, 48431, Germany

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Saarlouis, 66740, Germany

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Schwandorf in Bayern, 92421, Germany

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Schweinfurt, 97421, Germany

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Sindelfingen, 71063, Germany

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Sinsheim, 74889, Germany

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Tangermünde, 39590, Germany

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Trier, 54290, Germany

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Tübingen, 72076, Germany

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Ulm, 89077, Germany

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Velbert, 42549, Germany

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Wetzlar, 35578, Germany

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Wiesloch, 69168, Germany

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Worms, 67547, Germany

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Würzburg, 97072, Germany

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Würzburg, 97080, Germany

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Zwickau, 08056, Germany

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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-La Roche

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: November 15, 2007
• First Posted: November 16, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 6, 2016
• Results First Posted: April 6, 2016

Record last verified: 2016-03

Locations

DE (50)