Chronic Kidney DiseasesNCT02238067

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

An observational study of Chronic Kidney Diseases, run by Hoffmann-La Roche at 7 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Diseases
What is being tested?: ESA and Satisfaction Survey Questionnaire
How many people: 196 participants
Where: 7 sitesIsrael
Study dates: Sep 2011to Aug 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult participants with CKD not on-dialysis treated with ESAs

Who may be able to join

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

Who cannot join

Past or current treatment with dialysis

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Israel7 sites

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

Other trials in Israel

About this study

Official title: 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.

Conditions: Chronic Kidney Diseases
Being tested: ESA, Satisfaction Survey Questionnaire
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ESADrug
Participants will continue to receive their ESA treatment, as per physician's discretion. The study protocol does not specify any particular ESA drug.
Satisfaction Survey QuestionnaireOther
Each participant will be interviewed to complete treatment satisfaction questionnaire survey at baseline and at 6-month follow-up visit.

Study groups in NCT02238067
Study group	Role	What they receive
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. Receives: Drug: ESA; Other: Satisfaction Survey Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6

Secondary outcomes (14)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Aug 2013

First posted12 Sep 2014 (estimated)
Study startSep 2011
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02238067
Sponsor's protocol ID: ML25473
Status last verified: Feb 2017
First submitted: 10 Sep 2014
Last updated: 24 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survey on Anemia Therapy With ESAs Medication in Chronic Kidney Disease Patients Not on Dialysis
ClinicalTrials.gov ID: NCT02238067
Acronym / sponsor ID: ML25473
Conditions: Chronic Kidney Diseases
Study type: Observational
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Posted 7 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Chronic Renal Anemia Participants	–	Drug: ESA, Other: Satisfaction Survey QuestionnaireParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult participants with CKD not on-dialysis treated with ESAs

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Past or current treatment with dialysis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ESAParticipants will continue to receive their ESA treatment, as per physician's discretion. The study protocol does not specify any particular ESA drug.	Drug	Chronic Renal Anemia Participants
Satisfaction Survey QuestionnaireEach participant will be interviewed to complete treatment satisfaction questionnaire survey at baseline and at 6-month follow-up visit.	Other	Chronic Renal Anemia Participants

Primary outcome

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.
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.
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.
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.
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.
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.

14 secondary outcomes

Percentage of Participants by Different CKD Stages
Time frame: Baseline, Month 6
Percentage of Participants by Different Injection Administration Modes
Time frame: Baseline, Month 6
Percentage of Participants With Interest in Learning to Inject Independently
Time frame: Baseline, Month 6
Percentage of Participants by Need for Improvement in Treatment Frequency
Time frame: Baseline, Month 6
Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type
Time frame: Baseline, Month 6
Percentage of Participants by Preferred Treatment Frequency
Time frame: Baseline, Month 6
Percentage of Participants by Preferred Treatment Frequency by ESA Type
Time frame: Baseline, Month 6
Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency
Time frame: Baseline, Month 6
Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements
Time frame: Baseline, Month 6
Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types
Time frame: Baseline, Month 6
Percentage of Participants by Convenience of Syringe Usage
Time frame: Baseline, Month 6
Percentage of Participants by Convenience of Syringe Usage by ESA Type
Time frame: Baseline, Month 6
Percentage of Participants by Injection Site Pain
Time frame: Baseline, Month 6
Percentage of Participants by Injection Site Pain by ESA Type
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 7 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Renal Anemia Participants	196	151

Primary outcome: Percentage of Participants by ESA Types at Baseline

Time frame: Baseline. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Chronic Renal Anemia Participants n = 196
Mircera	51.5 (44.3 to 58.7)
Recormon	17.3 (12.3 to 23.4)
Eprex	10.7 (6.8 to 15.9)
Aranesp	20.4 (15.0 to 26.7)

Population analysed: All enrolled participants

Primary outcome: Percentage of Participants by ESA Types at Month 6

Time frame: Month 6. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Chronic Renal Anemia Participants n = 151
Mircera	43.7 (35.7 to 52.0)
Recormon	19.2 (13.3 to 26.4)
Eprex	12.6 (7.7 to 19.0)
Aranesp	24.5 (17.9 to 32.2)

Population analysed: All enrolled participants who completed the questionnaire at Month 6

Primary outcome: Percentage of Participants by Frequency of ESA Use at Baseline

Time frame: Baseline. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Chronic Renal Anemia Participants n = 195
Three times a week	2.6 (0.8 to 5.9)
Twice a week	7.2 (4.0 to 11.8)
Once a week	14.9 (10.2 to 20.7)
Every 2 weeks	26.2 (20.1 to 32.9)
Every 4 weeks	38.5 (31.6 to 45.7)
Other	10.8 (6.8 to 16.0)

Population analysed: All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants by Frequency of ESA Use at Month 6

Time frame: Month 6. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Chronic Renal Anemia Participants n = 151
Three times a week	1.3 (0.2 to 4.7)
Twice a week	4.0 (1.5 to 8.4)
Once a week	15.9 (10.5 to 22.7)
Every 2 weeks	25.2 (18.5 to 32.9)
Every 4 weeks	39.1 (31.2 to 47.3)
Other	14.6 (9.4 to 21.2)

Population analysed: All enrolled participants who completed the questionnaire at Month 6

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to Month 6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Renal Anemia Participants	3 of 196 (1.5%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): The study was completed as defined in the protocol. Only 196 participants (out of planned 400) were enrolled due to slow recruitment during the study period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Kidney Diseases

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases, run by Hoffmann-La Roche at 7 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants by ESA Types at Baseline (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02238067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.