A Study of NeoRecormon in Patients With Chronic Kidney Disease.

Hoffmann-La Roche90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

epoetin beta [NeoRecormon]DRUG

At a dose to achieve and maintain an Hb level of 120-135g/dL.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Belgrade, Serbia

Unnamed facility

Novi Sad, Serbia

Outcomes

Primary Outcomes

Hb level, decline in renal function, 24h proteinuria, creatinine clearance.

Time frame: Throughout study

Secondary Outcomes

SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.

Time frame: Throughout study

Data from ClinicalTrials.gov

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