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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: ESA
* Other: Satisfaction Survey Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Renal Anemia Participants<br>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<br>* Participants will continue to receive their ESA treatment, as per physician's discretion. The study protocol does not specify any particular ESA drug.<br>Other: Satisfaction Survey Questionnaire<br>* Each participant will be interviewed to complete treatment satisfaction questionnaire survey at baseline and at 6-month follow-up visit.<br>|

What is the study measuring?
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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 |