A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

NCT00442416 | Terminated Phase 3 Results

• 1 other identifier: ML20338
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 29

Brief Summary

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period

  Mean change in Hb concentration from Baseline (Day \[D\] 0) to average during the evaluation period (Month 7 to 9) is reported.

  From Baseline (D 0) to 9 months

Secondary Outcomes (14)

• Percentage of Participants With Safety-Related Hb Measures

  Up to Month 9

• Number of Participants With Marked Laboratory Abnormalities

  Up to Month 9

• Mean Change From Baseline in Iron

  From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8

• Mean Change From Baseline in Ferritin

  From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

• Mean Change From Baseline in Transferrin Saturation

  From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8

Study Arms (2)

RO0503821

EXPERIMENTAL

Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so.

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Epoetin Alfa

ACTIVE COMPARATOR

Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.

Drug: Epoetin alfa

Interventions

Epoetin alfa DRUG

As prescribed, SC

Epoetin Alfa

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

120-360 micrograms SC monthly, starting dose

RO0503821

Eligibility Criteria

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

You may qualify if:

• adult patients, \>=18 years of age;
• chronic kidney disease stage V;
• on peritoneal dialysis for 3 months prior to screening;
• on epoetin alfa sc \>=3 months prior to screening.

You may not qualify if:

• patients expecting to change dialysis modality over course of study;
• patients hospitalized during previous 3 months for any clinically significant condition;
• active malignancy;
• bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
• transfusion of red blood cells within 3 months prior to screening.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (29)

Unknown Facility

Birmingham, Alabama, 35213, United States

Location

Unknown Facility

Bakersfield, California, 93309, United States

Location

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Chula Vista, California, 91910, United States

Location

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Mountain View, California, 94041, United States

Location

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San Leandro, California, 94578, United States

Location

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Simi Valley, California, 93065, United States

Location

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Whittier, California, 90602, United States

Location

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Lakewood, Colorado, 80214, United States

Location

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Stamford, Connecticut, 06902, United States

Location

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Ocala, Florida, 34471, United States

Location

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Pembroke Pines, Florida, 33028, United States

Location

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Augusta, Georgia, 30901, United States

Location

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Marietta, Georgia, 30060, United States

Location

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Wichita, Kansas, 67214, United States

Location

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Detroit, Michigan, 48236, United States

Location

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Pontiac, Michigan, 48341, United States

Location

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Flushing, New York, 11355, United States

Location

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Syracuse, New York, 13212, United States

Location

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Williamsville, New York, 14221, United States

Location

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Dayton, Ohio, 45408, United States

Location

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Toledo, Ohio, 43606, United States

Location

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Tulsa, Oklahoma, 74120, United States

Location

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Lewistown, Pennsylvania, 17044, United States

Location

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Philadelphia, Pennsylvania, 19106, United States

Location

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Dyersburg, Tennessee, 38024, United States

Location

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San Antonio, Texas, 78215, United States

Location

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Tyler, Texas, 75701, United States

Location

Unknown Facility

Alexandria, Virginia, 22304, United States

Location

Unknown Facility

Richmond, Virginia, 23229, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa; continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

The study was prematurely terminated during enrollment period due to legal reasons. Therefore, the planned statistical analysis of the primary endpoint was not performed.

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 2, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 17, 2016
• Results First Posted: August 17, 2016

Record last verified: 2016-07

Locations

US (29)