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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02238067
Other study ID # ML25473
Secondary ID
Status Completed
Phase N/A
First received September 10, 2014
Last updated August 1, 2016
Start date September 2011
Est. completion date August 2013

Study information

Verified date August 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Israel:Ethics Committee
Study type Observational

Clinical Trial Summary

This study is a prospective, non-interventional, cross-sectional multicenter survey. The aim is to better understand the current therapy pattern for anemia in chronic kidney disease (CKD) treated with erythropoiesis-stimulating agents (ESAs) and not on-dialysis patient population in Israel. Participating physicians will be requested to complete a satisfaction survey for anemia treatment for eligible patients with CKD not on dialysis. The survey will be completed twice, once at study start and once at six months' follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients with CKD stage 3-5

- Treated with ESAs

- Written informed consent

- Patient is speaking the same language as the investigator interviewer

Exclusion Criteria:

- Past or current treatment with dialysis

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients according to the different ESAs, frequency of use Until study completion, maximum period of 2 years No
Secondary Patients' preference for treatment frequency as assessed by physician via a satisfaction survey At study start and at 6 months follow-up No
Secondary Patients' preference for treatment administration methods, by physician via a satisfaction survey At study start and at 6 months follow-up No
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