An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant

Roche

Status: Completed

Conditions: Anemia, Kidney Transplantation

Treatments: Drug: Methoxy-polyethyleneglycol epoetin beta

Study type: Observational

Funder types: Industry

Identifiers

NCT02538107

ML21386

Details and patient eligibility

About

This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collected over 15 months of Mircera therapy.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with kidney transplant and a chronic kidney disease (CKD), who need erythropoiesis stimulating agent (ESA) therapy as part of their medical care and prescribed methoxy polyethyleneglycol-epoetin beta by the doctor.
• The transplant should function regularly and without need of continuous dialysis treatment at inclusion and also during the documentation period of this study according to treating physician's prognosis.

Exclusion criteria

• Kidney transplantation dates back less than 3 months. Acute decrease of hemoglobin (Hb) before enrollment, defined as decrease of greater than or equal to (>/=) 2 g/dL between two sequential values.
• Administration of other ESA therapies during the observation period.

Trial design

290 participants in 1 patient group

Kidney Transplant Participants

Description:

Participants with kidney transplant and a chronic kidney disease who were receiving methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care.

Treatment:

Drug: Methoxy-polyethyleneglycol epoetin beta