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

February 21, 2017 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants by ESA Types at Baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants by Different CKD Stages
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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
Time Frame: Baseline, Month 6
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML25473

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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