A Study of NeoRecormon in Patients With Chronic Kidney Disease.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

epoetin beta [NeoRecormon]

Intervention Type DRUG

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

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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epoetin beta [NeoRecormon]

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No