NCT01105494

Brief Summary

This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta \[Neorecormon\] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 13, 2012

Status Verified

June 1, 2011

Enrollment Period

3.5 years

First QC Date

April 14, 2010

Last Update Submit

September 12, 2012

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Quality of life assessment: Kidney Disease Quality of Life Questionnaire

    Throughout study: 6 months

Secondary Outcomes (1)

  • Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life

    Throughout study: 6 months

Interventions

epoetin beta [NeoRecormon]DRUG

As prescribed by physician

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dialysis patients with end-stage kidney disease on treatment with epoetin beta \[Neorecormon\]

You may qualify if:

  • Adult patients \>/=18 years of age
  • Dialysis patients with chronic renal anemia
  • Written informed consent

You may not qualify if:

  • Red blood cell transfusion in the previous 2 months
  • Severe neuropsychological disorder
  • Diabetic patients with serious complications
  • This trial is being conducted in Morocco.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Casablanca, 20000, Morocco

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 16, 2010

Study Start

December 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 13, 2012

Record last verified: 2011-06

Locations

MO(1)