Clinical trial NCT02238067: Survey on Anemia Therapy in Participants With Chronic Kidney Disease (CKD) Not on Dialysis
Official title: Survey on Anemia Therapy With ESAs Medication in Chronic Kidney Disease Patients Not on Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with CKD not on-dialysis treated with ESAs

Brief 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 CKD treated with erythropoiesis-stimulating agents (ESAs) and not on-dialysis participant population in Israel. Participating physicians will be requested to interview eligible participants with CKD not on dialysis and to complete for them a satisfaction survey for anemia treatment. The survey will be completed twice, once at study start and once at six months' follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult participants with CKD Stage 3-5
* Treated with ESAs
* Participant is speaking the same language as the investigator interviewer

Exclusion Criteria:

* Past or current treatment with dialysis

Primary outcomes:
measure: Percentage of Participants by ESA Types at Baseline
timeFrame: Baseline
measure: Percentage of Participants by ESA Types at Month 6
timeFrame: Month 6
measure: Percentage of Participants by Frequency of ESA Use at Baseline
timeFrame: Baseline
measure: Percentage of Participants by Frequency of ESA Use at Month 6
timeFrame: Month 6
measure: Percentage of Participants by Frequency and Types of ESA Used at Baseline
timeFrame: Baseline
measure: Percentage of Participants by Frequency and Types of ESA Used at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants by Different CKD Stages
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Different Injection Administration Modes
timeFrame: Baseline, Month 6
measure: Percentage of Participants With Interest in Learning to Inject Independently
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Need for Improvement in Treatment Frequency
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Preferred Treatment Frequency
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Preferred Treatment Frequency by ESA Type
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Convenience of Syringe Usage
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Convenience of Syringe Usage by ESA Type
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Injection Site Pain
timeFrame: Baseline, Month 6
measure: Percentage of Participants by Injection Site Pain by ESA Type
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Carmiel
country: Israel
facility: Clalit Carmiel
city: Ganey Tikva
country: Israel
facility: Clalit- New Savyon Clinic
city: Jerusalem
country: Israel
facility: Clalit - Diabetic HaMoshava South Clinic
city: Kiryat Bialik
country: Israel
facility: Clalit - Professional Clinic, Zvulun
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Nephrology and Hypertension Services
city: Tel Aviv
country: Israel
facility: Clalit- Migdal HaMea Clinic, Tel Aviv
city: Upper Nazareth
country: Israel
facility: Clalit Ben-Gurion
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: