Survey on Anemia Therapy in Participants With Chronic Kidney Disease (CKD) Not on Dialysis

Survey on Anemia Therapy With ESAs Medication in Chronic Kidney Disease Patients Not on Dialysis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: ESA; Other: Satisfaction Survey Questionnaire

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Israel
  • Carmiel, Israel
    • Clalit Carmiel
  • Ganey Tikva, Israel
    • Clalit- New Savyon Clinic
  • Jerusalem, Israel
    • Clalit - Diabetic HaMoshava South Clinic
  • Kiryat Bialik, Israel
    • Clalit - Professional Clinic, Zvulun
  • Rehovot, Israel, 76100
    • Kaplan Medical Center; Nephrology and Hypertension Services
  • Tel Aviv, Israel
    • Clalit- Migdal HaMea Clinic, Tel Aviv
  • Upper Nazareth, Israel
    • Clalit Ben-Gurion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with CKD not on-dialysis treated with ESAs

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Renal Anemia Participants; Participants with CKD who are not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, will be interviewed by physician who will complete the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.	Drug: ESA; Participants will continue to receive their ESA treatment, as per physician's discretion. The study protocol does not specify any particular ESA drug.; Other: Satisfaction Survey Questionnaire; Each participant will be interviewed to complete treatment satisfaction questionnaire survey at baseline and at 6-month follow-up visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants by ESA Types at Baseline	Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.	Baseline
Percentage of Participants by ESA Types at Month 6	Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.	Month 6
Percentage of Participants by Frequency of ESA Use at Baseline	Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.	Baseline
Percentage of Participants by Frequency of ESA Use at Month 6	Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.	Month 6
Percentage of Participants by Frequency and Types of ESA Used at Baseline	Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.	Baseline
Percentage of Participants by Frequency and Types of ESA Used at Month 6	Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants by Different CKD Stages	Assessment was performed by physician via a satisfaction survey on anemia treatment. CKD stages were based on participant's answer to the survey question. No specific method of assessment for CKD stage was specified. Percentage of participants with each CKD stage was reported.	Baseline, Month 6
Percentage of Participants by Different Injection Administration Modes	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked: 'How do you currently inject the anemia treatment?' and reported any of the 5 possible answers: Independently, by a family member, nurse at home, nurse at the clinic or other. Percentage of participants with each injection administration modes was reported.	Baseline, Month 6
Percentage of Participants With Interest in Learning to Inject Independently	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants responded 'yes' or 'no' to the question: 'Would you be interested in learning to inject independently?' ' Percentage of participants who responded 'yes', was reported.	Baseline, Month 6
Percentage of Participants by Need for Improvement in Treatment Frequency	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their need for improvement in the frequency of treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'Improvement is very necessary'. Percentage of participants with each score was reported.	Baseline, Month 6
Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their need for improvement in the frequency of each treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'improvement is very necessary'. Percentage of participants with each score and ESA type was reported.	Baseline, Month 6
Percentage of Participants by Preferred Treatment Frequency	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked "Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?". Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency was reported.	Baseline, Month 6
Percentage of Participants by Preferred Treatment Frequency by ESA Type	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and their preference of treatment frequency. Participants were asked "Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?". Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency and ESA type was reported.	Baseline, Month 6
Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for their preference of treatment frequency and baseline ESA frequency. Participants were asked "Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?". Preferred treatment frequency included: once a month (O/M), twice a month (B/M), once a week (O/W), twice a week (B/W), three times a week (T/W) or other (any other frequency]). Frequency of baseline ESA use included: three times a week, twice a week, once a week, every 2 weeks (Q2W), every 4 weeks (Q4W) or other (any other frequency). Percentage of participants by each preferred treatment frequency and baseline ESA frequency was reported.	Baseline, Month 6
Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score was reported.	Baseline, Month 6
Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score and ESA type was reported.	Baseline, Month 6
Percentage of Participants by Convenience of Syringe Usage	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score was reported.	Baseline, Month 6
Percentage of Participants by Convenience of Syringe Usage by ESA Type	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score and ESA type was reported.	Baseline, Month 6
Percentage of Participants by Injection Site Pain	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score was reported.	Baseline, Month 6
Percentage of Participants by Injection Site Pain by ESA Type	Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score and ESA type was reported.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: ML25473