A Study of NeoRecormon in Patients With Chronic Kidney Disease.

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: epoetin beta [NeoRecormon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437723

ML20200

Details and patient eligibility

About

This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients,18-75 years of age;
• end-stage renal disease, not on dialysis;
• Hb <110g/L.

Exclusion criteria

• unstable hypertension;
• acute infections;
• use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
• myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: epoetin beta [NeoRecormon]

2

No Intervention group

Sponsor of this trial

Lead Sponsor

Roche