NCT00437723

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 14, 2009

Status Verified

May 1, 2009

First QC Date

February 19, 2007

Last Update Submit

May 13, 2009

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

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

    Throughout study

Secondary Outcomes (1)

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

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: epoetin beta [NeoRecormon]

2

NO INTERVENTION

Interventions

epoetin beta [NeoRecormon]DRUG

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

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Belgrade, 11000, Serbia

Location

Unknown Facility

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 19, 2007

First Posted

February 21, 2007

Study Completion

April 1, 2008

Last Updated

May 14, 2009

Record last verified: 2009-05

Locations

SE(2)