A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02827266

ML18730

Details and patient eligibility

About

This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or 2 diabetes
• Chronic renal failure (stage 2 to stage 5) defined by Glomerular Filtration Rate (GFR) less than (<) 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2)
• Anemia related to chronic kidney disease and requiring treatment with erythropoiesis-stimulating agent (ESA) (2 values of hemoglobin less than or equal to 11 gram per deciliter [g/dL] during the 3 months prior to inclusion), and hemoglobin greater than 8 g/dL

Exclusion criteria

• Anemia due to a non-renal cause
• Poorly controlled hypertension
• Treatment with an erythropoiesis stimulating agent (ESA) within 3 months prior to the study
• Planned dialysis in next 3 months or organ transplant
• History of cancer except for basal cell cancer and cervical cancer in situ

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

Epoetin beta

Experimental group

Description:

Participants will receive epoetin beta over an 8-week correction phase and a 4-week extension or continuation phase, for a total exposure of up to 12 weeks.

Treatment:

Drug: Epoetin beta