A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

NCT ID: NCT01342640

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-18
• Study Completion Date: 2012-11-30

Brief Summary

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

Conditions

Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type: DRUG

Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]

Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients, age >/=18 years
• Diagnosis of chronic renal anemia
• Not on dialysis
• Hemoglobin concentration <10 g/dl
• No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
• Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
• Adequate iron status

Exclusion Criteria

• Transfusion of red blood cells during the previous 2 months
• Poorly controlled hypertension
• Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
• Active malignant disease (except non-melanoma skin cancer)
• Hemolysis
• Hemoglobinopathies, e.g. sickle-cell disease, thalassemia

• 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

Mansoura Kidney Center; Nephrology

Al Mansurah, , Egypt

Alexandria University; Endocrinology Department

Alexandria, , Egypt

El Qahira Al Fatemeya Hospital

Cairo, , Egypt

Kasr El Ainy University Hospital; Endocrinology Department

Cairo, , Egypt

Nasser Institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

ML25300

Identifier Type: -

Identifier Source: org_study_id