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

NCT ID: NCT00442416

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RO0503821

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.

Group Type: EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type: DRUG

120-360 micrograms SC monthly, starting dose

Epoetin Alfa

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.

Group Type: ACTIVE_COMPARATOR

Epoetin alfa

Intervention Type: DRUG

As prescribed, SC

Interventions

Epoetin alfa

As prescribed, SC

Intervention Type: DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

120-360 micrograms SC monthly, starting dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Birmingham, Alabama, United States

Bakersfield, California, United States

Chula Vista, California, United States

Mountain View, California, United States

San Leandro, California, United States

Simi Valley, California, United States

Whittier, California, United States

Lakewood, Colorado, United States

Stamford, Connecticut, United States

Ocala, Florida, United States

Pembroke Pines, Florida, United States

Augusta, Georgia, United States

Marietta, Georgia, United States

Wichita, Kansas, United States

Detroit, Michigan, United States

Pontiac, Michigan, United States

Flushing, New York, United States

Syracuse, New York, United States

Williamsville, New York, United States

Dayton, Ohio, United States

Toledo, Ohio, United States

Tulsa, Oklahoma, United States

Lewistown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Dyersburg, Tennessee, United States

San Antonio, Texas, United States

Tyler, Texas, United States

Alexandria, Virginia, United States

Richmond, Virginia, United States

Countries

United States

Other Identifiers

ML20338

Identifier Type: -

Identifier Source: org_study_id