CClinicalTrials.gg
CompletedNCT02238067Updated Mar 24, 2017Results posted

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

An observational study in Chronic Kidney Diseases, sponsored by Hoffmann-La Roche. Completed at 7 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
196
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Diseases
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 196 is close to the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants with CKD not on-dialysis treated with ESAs

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Past or current treatment with dialysis
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
196 participants (actual)

Groups and cohorts

  • 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 · Other: Satisfaction Survey Questionnaire

Interventions

  • DrugESA

    Participants will continue to receive their ESA treatment, as per physician's discretion. The study protocol does not specify any particular ESA drug.

  • OtherSatisfaction Survey Questionnaire

    Each participant will be interviewed to complete treatment satisfaction questionnaire survey at baseline and at 6-month follow-up visit.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Month 6

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Month 6

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: Month 6

Secondary outcomes

  1. 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.

    Time frame: Baseline, Month 6

  2. 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.

    Time frame: Baseline, Month 6

  3. 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.

    Time frame: Baseline, Month 6

  4. 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.

    Time frame: Baseline, Month 6

  5. 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.

    Time frame: Baseline, Month 6

  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.

    Time frame: Baseline, Month 6

  7. 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.

    Time frame: Baseline, Month 6

  8. 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.

    Time frame: Baseline, Month 6

  9. 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.

    Time frame: Baseline, Month 6

  10. 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.

    Time frame: Baseline, Month 6

  11. 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.

    Time frame: Baseline, Month 6

  12. 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.

    Time frame: Baseline, Month 6

  13. 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.

    Time frame: Baseline, Month 6

  14. 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.

    Time frame: Baseline, Month 6

07

Results

Posted Nov 6, 2016
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneChronic Renal Anemia Participants
Started196
Completed151
Not completed45
Withdrew: Not completed survey at month 645

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline
Reported as:
Number · percentage of participants
Percentage of Participants by ESA Types at Baseline
percentage of participantsChronic Renal Anemia Participants
Mircera51.5 (44.3 to 58.7)
Recormon17.3 (12.3 to 23.4)
Eprex10.7 (6.8 to 15.9)
Aranesp20.4 (15.0 to 26.7)
PrimaryPercentage 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.

Time frame:
Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by ESA Types at Month 6
percentage of participantsChronic Renal Anemia Participants
Mircera43.7 (35.7 to 52.0)
Recormon19.2 (13.3 to 26.4)
Eprex12.6 (7.7 to 19.0)
Aranesp24.5 (17.9 to 32.2)
PrimaryPercentage 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.

Time frame:
Baseline
Reported as:
Number · percentage of participants
Percentage of Participants by Frequency of ESA Use at Baseline
percentage of participantsChronic Renal Anemia Participants
Three times a week2.6 (0.8 to 5.9)
Twice a week7.2 (4.0 to 11.8)
Once a week14.9 (10.2 to 20.7)
Every 2 weeks26.2 (20.1 to 32.9)
Every 4 weeks38.5 (31.6 to 45.7)
Other10.8 (6.8 to 16.0)
PrimaryPercentage 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.

Time frame:
Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Frequency of ESA Use at Month 6
percentage of participantsChronic Renal Anemia Participants
Three times a week1.3 (0.2 to 4.7)
Twice a week4.0 (1.5 to 8.4)
Once a week15.9 (10.5 to 22.7)
Every 2 weeks25.2 (18.5 to 32.9)
Every 4 weeks39.1 (31.2 to 47.3)
Other14.6 (9.4 to 21.2)
PrimaryPercentage 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.

Time frame:
Baseline
Reported as:
Number · percentage of participants
Percentage of Participants by Frequency and Types of ESA Used at Baseline
percentage of participantsChronic Renal Anemia Participants
Mircera : Three times a week (n=100)2.0
Mircera : Twice a week (n=100)4.0
Mircera : Once a week (n=100)1.0
Mircera : Every 2 weeks (n=100)26.0
Mircera : Every 4 weeks (n=100)67.0
Mircera : Other (n=100)0
Recormon : Three times a week (n=34)0
Recormon : Twice a week (n=34)17.6
Recormon : Once a week (n=34)38.2
Recormon : Every 2 weeks (n=34)17.6
Recormon : Every 4 weeks (n=34)5.9
Recormon : Other (n=34)20.6
Eprex : Three times a week (n=21)9.5
Eprex : Twice a week (n=21)9.5
Eprex : Once a week (n=21)42.9
Eprex : Every 2 weeks (n=21)9.5
Eprex : Every 4 weeks (n=21)4.8
Eprex : Other (n=21)23.8
Aranesp : Three times a week (n=40)2.5
Aranesp : Twice a week (n=40)5.0
Aranesp : Once a week (n=40)15.0
Aranesp : Every 2 weeks (n=40)42.5
Aranesp : Every 4 weeks (n=40)12.5
Aranesp : Other (n=40)22.5
PrimaryPercentage 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.

Time frame:
Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Frequency and Types of ESA Used at Month 6
percentage of participantsChronic Renal Anemia Participants
Mircera : Three times a week (n=66)1.5
Mircera : Twice a week (n=66)1.5
Mircera : Once a week (n=66)0
Mircera : Every 2 weeks (n=66)18.2
Mircera : Every 4 weeks (n=66)71.2
Mircera : Other (n=66)7.6
Recormon : Three times a week (n=29)0
Recormon : Twice a week (n=29)10.3
Recormon : Once a week (n=29)27.6
Recormon : Every 2 weeks (n=29)37.9
Recormon : Every 4 weeks (n=29)6.9
Recormon : Other (n=29)17.2
Eprex : Three times a week (n=19)5.3
Eprex : Twice a week (n=19)5.3
Eprex : Once a week (n=19)47.4
Eprex : Every 2 weeks (n=19)15.8
Eprex : Every 4 weeks (n=19)5.3
Eprex : Other (n=19)21.1
Aranesp : Three times a week (n=37)0
Aranesp : Twice a week (n=37)2.7
Aranesp : Once a week (n=37)18.9
Aranesp : Every 2 weeks (n=37)32.4
Aranesp : Every 4 weeks (n=37)24.3
Aranesp : Other (n=37)21.6
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Different CKD Stages
percentage of participantsChronic Renal Anemia Participants
Stage 1 : Baseline (n=196)2.0
Stage 1 : Month 6 (n=151)1.3
Stage 2 : Baseline (n=196)10.2
Stage 2 : Month 6 (n=151)13.9
Stage 3 : Baseline (n=196)37.8
Stage 3 : Month 6 (n=151)41.7
Stage 4 : Baseline (n=196)37.8
Stage 4 : Month 6 (n=151)30.5
Stage 5 : Baseline (n=196)12.2
Stage 5 : Month 6 (n=151)12.6
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Different Injection Administration Modes
percentage of participantsChronic Renal Anemia Participants
Independently : Baseline (n=196)18.4
Independently : Month 6 (n=151)23.2
By a family member : Baseline (n=196)16.8
By a family member : Month 6 (n=151)17.9
Nurse at home : Baseline (n=196)3.6
Nurse at home : Month 6 (n=151)3.3
Nurse at the clinic : Baseline (n=196)58.2
Nurse at the clinic : Month 6 (n=151)52.3
Other: Baseline (n=196)3.1
Other : Month 6 (n=151)3.3
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants With Interest in Learning to Inject Independently
percentage of participantsChronic Renal Anemia Participants
Baseline (n=160)6.3 (3.0 to 11.2)
Month 6 (n=116)4.3 (1.4 to 9.8)
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Need for Improvement in Treatment Frequency
percentage of participantsChronic Renal Anemia Participants
Score 1 : Baseline (n=196)94.9 (90.8 to 97.5)
Score 1 : Month 6 (n=151)96.0 (91.6 to 98.5)
Score 2 : Baseline (n=196)1.5 (0.3 to 4.4)
Score 2 : Month 6 (n=151)1.3 (0.2 to 4.7)
Score 3 : Baseline (n=196)1.5 (0.3 to 4.4)
Score 3 : Month 6 (n=151)1.3 (0.2 to 4.7)
Score 4 : Baseline (n=196)1.5 (0.3 to 4.4)
Score 4 : Month 6 (n=151)0.7 (0 to 3.6)
Score 5 : Baseline (n=196)0.5 (0 to 2.8)
Score 5 : Month 6 (n=151)0.7 (0 to 3.6)
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type
percentage of participantsChronic Renal Anemia Participants
Mircera: Score 1: Baseline (n=101)98.0
Mircera: Score 2: Baseline (n=101)2.0
Mircera: Score 3: Baseline (n=101)0
Mircera: Score 4: Baseline (n=101)0
Mircera: Score 5: Baseline (n=101)0
Recormon: Score 1: Baseline (n=34)94.1
Recormon: Score 2: Baseline (n=34)0
Recormon: Score 3: Baseline (n=34)0
Recormon: Score 4: Baseline (n=34)2.9
Recormon: Score 5: Baseline (n=34)2.9
Eprex: Score 1: Baseline (n=21)90.5
Eprex: Score 2: Baseline (n=21)0
Eprex: Score 3: Baseline (n=21)9.5
Eprex: Score 4: Baseline (n=21)0
Eprex: Score 5: Baseline (n=21)0
Aranesp: Score 1: Baseline (n=40)90.0
Aranesp: Score 2: Baseline (n=40)2.5
Aranesp: Score 3: Baseline (n=40)2.5
Aranesp: Score 4: Baseline (n=40)5.0
Aranesp: Score 5: Baseline (n=40)0
Mircera: Score 1: Month 6 (n=66)100.0
Mircera: Score 2: Month 6 (n=66)0
Mircera: Score 3: Month 6 (n=66)0
Mircera: Score 4: Month 6 (n=66)0
Mircera: Score 5: Month 6 (n=66)0
Recormon: Score 1: Month 6 (n=29)96.6
Recormon: Score 2: Month 6 (n=29)0
Recormon: Score 3: Month 6 (n=29)3.4
Recormon: Score 4: Month 6 (n=29)0
Recormon: Score 5: Month 6 (n=29)0
Eprex: Score 1: Month 6 (n=19)94.7
Eprex: Score 2: Month 6 (n=19)5.3
Eprex: Score 3: Month 6 (n=19)0
Eprex: Score 4: Month 6 (n=19)0
Eprex: Score 5: Month 6 (n=19)0
Aranesp: Score 1: Month 6 (n=37)89.2
Aranesp: Score 2: Month 6 (n=37)2.7
Aranesp: Score 3: Month 6 (n=37)2.7
Aranesp: Score 4: Month 6 (n=37)2.7
Aranesp: Score 5: Month 6 (n=37)2.7
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Preferred Treatment Frequency
percentage of participantsChronic Renal Anemia Participants
Once a month: Baseline (n=196)63.8 (56.6 to 70.5)
Once a month: Month 6 (n=151)49.0 (40.8 to 57.3)
Twice a month: Baseline (n=196)17.3 (12.3 to 23.4)
Twice a month: Month 6 (n=151)23.8 (17.3 to 31.4)
Once a week: Baseline (n=196)12.8 (8.4 to 18.3)
Once a week: Month 6 (n=151)17.2 (11.6 to 24.2)
Twice a week: Baseline (n=196)2.0 (0.6 to 5.1)
Twice a week: Month 6 (n=151)2.0 (0.4 to 5.7)
Three times a week: Baseline (n=196)1.0 (0.1 to 3.6)
Three times a week: Month 6 (n=151)0.7 (0 to 3.6)
Other: Baseline (n=196)3.1 (1.1 to 6.5)
Other: Month 6 (n=151)7.3 (3.7 to 12.7)
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Preferred Treatment Frequency by ESA Type
percentage of participantsChronic Renal Anemia Participants
Mircera: Once a month: Baseline (n=101)83.2
Mircera: Once a month: Month 6 (n=66)75.8
Mircera: Twice a month: Baseline (n=101)14.9
Mircera: Twice a month: Month 6 (n=66)15.2
Mircera: Once a week: Baseline (n=101)1.0
Mircera: Once a week: Month 6 (n=66)3.0
Mircera: Twice a week: Baseline (n=101)1.0
Mircera: Twice a week: Month 6 (n=66)0
Mircera: Three times a week: Baseline (n=101)0
Mircera: Three times a week: Month 6 (n=66)0
Mircera: Other: Baseline (n=101)0
Mircera: Other: Month 6 (n=66)6.1
Recormon: Once a month: Baseline (n=34)44.1
Recormon: Once a month: Month 6 (n=29)27.6
Recormon: Twice a month: Baseline (n=34)14.7
Recormon: Twice a month: Month 6 (n=29)31.0
Recormon: Once a week: Baseline (n=34)35.3
Recormon: Once a week: Month 6 (n=29)31.0
Recormon: Twice a week: Baseline (n=34)2.9
Recormon: Twice a week: Month 6 (n=29)6.9
Recormon: Three times a week: Baseline (n=34)0
Recormon: Three times a week: Month 6 (n=29)3.4
Recormon: Other: Baseline (n=34)2.9
Recormon: Other: Month 6 (n=29)0
Eprex: Once a month: Baseline (n=21)33.3
Eprex: Once a month: Month 6 (n=19)10.5
Eprex: Twice a month: Baseline (n=21)0
Eprex: Twice a month: Month 6 (n=19)15.8
Eprex: Once a week: Baseline (n=21)42.9
Eprex: Once a week: Month 6 (n=19)52.6
Eprex: Twice a week: Baseline (n=21)9.5
Eprex: Twice a week: Month 6 (n=19)5.3
Eprex: Three times a week: Baseline (n=21)4.8
Eprex: Three times a week: Month 6 (n=19)0
Eprex: Other: Baseline (n=21)9.5
Eprex: Other: Month 6 (n=19)15.8
Aranesp: Once a month: Baseline (n=40)47.5
Aranesp: Once a month: Month 6 (n=37)37.8
Aranesp: Twice a month: Baseline (n=40)35.0
Aranesp: Twice a month: Month 6 (n=37)37.8
Aranesp: Once a week: Baseline (n=40)7.5
Aranesp: Once a week: Month 6 (n=37)13.5
Aranesp: Twice a week: Baseline (n=40)0
Aranesp: Twice a week: Month 6 (n=37)0
Aranesp: Three times a week: Baseline (n=40)2.5
Aranesp: Three times a week: Month 6 (n=37)0
Aranesp: Other: Baseline (n=40)7.5
Aranesp: Other: Month 6 (n=37)10.8
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency
percentage of participantsChronic Renal Anemia Participants
Preferred O/M: Baseline ESA T/W: Baseline (n=5)80.0
Preferred O/M: Baseline ESA T/W: Month 6 (n=2)50.0
Preferred O/M: Baseline ESA B/W: Baseline (n=14)28.6
Preferred O/M: Baseline ESA B/W: Month 6 (n=6)0
Preferred O/M: Baseline ESA O/W: Baseline (n=29)27.6
Preferred O/M: Baseline ESA O/W: Month 6 (n=24)12.5
Preferred O/M: Baseline ESA Q2W: Baseline (n=51)49.0
Preferred O/M: Baseline ESA Q2W: Month 6 (n=38)13.2
Preferred O/M: Baseline ESA Q4W: Baseline (n=75)98.7
Preferred O/M: Baseline ESA Q4W: Month 6 (n=59)96.6
Preferred O/M: Baseline ESA other: Baseline (n=21)47.6
Preferred O/M: Baseline ESA other: Month 6 (n=22)36.4
Preferred B/M: Baseline ESA T/W: Baseline (n=5)0
Preferred B/M: Baseline ESA T/W: Month 6 (n=2)0
Preferred B/M: Baseline ESA B/W: Baseline (n=14)28.6
Preferred B/M: Baseline ESA B/W: Month 6 (n=6)33.3
Preferred B/M: Baseline ESA O/W: Baseline (n=29)10.3
Preferred B/M: Baseline ESA O/W: Month 6 (n=24)8.3
Preferred B/M: Baseline ESA Q2W: Baseline (n=51)47.1
Preferred B/M: Baseline ESA Q2W: Month 6 (n=38)81.6
Preferred B/M: Baseline ESA Q4W: Baseline (n=75)0
Preferred B/M: Baseline ESA Q4W: Month 6 (n=59)0
Preferred B/M: Baseline ESA other: Baseline (n=21)9.5
Preferred B/M: Baseline ESA other: Month 6 (n=22)4.5
Preferred O/W: Baseline ESA T/W: Baseline (n=5)0
Preferred O/W: Baseline ESA T/W: Month 6 (n=2)50.0
Preferred O/W: Baseline ESA B/W: Baseline (n=14)28.6
Preferred O/W: Baseline ESA B/W: Month 6 (n=6)33.3
Preferred O/W: Baseline ESA O/W: Baseline (n=29)62.1
Preferred O/W: Baseline ESA O/W: Month 6 (n=24)79.2
Preferred O/W: Baseline ESA Q2W: Baseline (n=51)2.0
Preferred O/W: Baseline ESA Q2W: Month 6 (n=38)2.6
Preferred O/W: Baseline ESA Q4W: Baseline (n=75)0
Preferred O/W: Baseline ESA Q4W: Month 6 (n=59)1.7
Preferred O/W: Baseline ESA other: Baseline (n=21)9.5
Preferred O/W: Baseline ESA other: Month 6 (n=22)9.1
Preferred B/W: Baseline ESA T/W: Baseline (n=5)0
Preferred B/W: Baseline ESA T/W: Month 6 (n=2)0
Preferred B/W: Baseline ESA B/W: Baseline (n=14)14.3
Preferred B/W: Baseline ESA B/W: Month 6 (n=6)33.3
Preferred B/W: Baseline ESA O/W: Baseline (n=29)0
Preferred B/W: Baseline ESA O/W: Month 6 (n=24)0
Preferred B/W: Baseline ESA Q2W: Baseline (n=51)2.0
Preferred B/W: Baseline ESA Q2W: Month 6 (n=38)2.6
Preferred B/W: Baseline ESA Q4W: Baseline (n=75)0
Preferred B/W: Baseline ESA Q4W: Month 6 (n=59)0
Preferred B/W: ESA other: Baseline (n=21)4.8
Preferred B/W: ESA other: Month 6 (n=22)0
Preferred T/W: Baseline ESA T/W: Baseline (n=5)20.0
Preferred T/W: Baseline ESA T/W: Month 6 (n=2)0
Preferred T/W: Baseline ESA B/W: Baseline (n=14)0
Preferred T/W: Baseline ESA B/W: Month 6 (n=6)0
Preferred T/W: Baseline ESA O/W: Baseline (n=29)0
Preferred T/W: Baseline ESA O/W: Month 6 (n=24)0
Preferred T/W: Baseline ESA Q2W: Baseline (n=51)0
Preferred T/W: Baseline ESA Q2W: Month 6 (n=38)0
Preferred T/W: Baseline ESA Q4W: Baseline (n=75)1.3
Preferred T/W: Baseline ESA Q4W: Month 6 (n=59)1.7
Preferred T/W: Baseline ESA other: Baseline (n=21)0
Preferred T/W: Baseline ESA other: Month 6 (n=22)0
Preferred Other: Baseline ESA T/W: Baseline (n=5)0
Preferred Other: Baseline ESA T/W: Month 6 (n=2)0
Preferred Other: Baseline ESA B/W: Baseline (n=14)0
Preferred Other: Baseline ESA B/W: Month 6 (n=6)0
Preferred Other: Baseline ESA O/W: Month 6 (n=29)0
Preferred Other: Baseline ESA O/W: Month 6 (n=24)0
Preferred Other: Baseline ESA Q2W: Baseline (n=51)0
Preferred Other: Baseline ESA Q2W: Month 6 (n=38)0
Preferred Other: Baseline ESA Q4W: Baseline (n=75)0
Preferred Other: Baseline ESA Q4W: Month 6 (n=59)0
Preferred Other:Baseline ESA other:Baseline (n=21)28.6
Preferred Other:Baseline ESA other: Month 6 (n=22)50.0
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements
percentage of participantsChronic Renal Anemia Participants
Score 1: Baseline (n=196)96.4 (92.8 to 98.6)
Score 1: Month 6 (n=151)97.4 (93.4 to 99.3)
Score 2: Baseline (n=196)1.0 (0.1 to 3.6)
Score 2: Month 6 (n=151)0.7 (0 to 3.6)
Score 3: Baseline (n=196)0 (0 to 0)
Score 3: Month 6 (n=151)1.3 (0.2 to 4.7)
Score 4: Baseline (n=196)0.5 (0 to 2.8)
Score 4: Month 6 (n=151)0 (0 to 0)
Score 5: Baseline (n=196)2.0 (0.6 to 5.1)
Score 5: Month 6 (n=151)0.7 (0 to 3.6)
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types
percentage of participantsChronic Renal Anemia Participants
Mircera: Score 1: Baseline (n=101)97.0
Mircera: Score 2: Baseline (n=101)1.0
Mircera: Score 4: Baseline (n=101)0
Mircera: Score 5: Baseline (n=101)2.0
Mircera: Score 1: Month 6 (n=66)100.0
Mircera: Score 2: Month 6 (n=66)0
Mircera: Score 3: Month 6 (n=66)0
Mircera: Score 5: Month 6 (n=66)0
Recormon: Score 1: Baseline (n=34)100.0
Recormon: Score 2: Baseline (n=340
Recormon: Score 4: Baseline (n=340
Recormon: Score 5: Baseline (n=340
Recormon: Score 1: Month 6 (n=29)96.6
Recormon: Score 2: Month 6 (n=29)3.4
Recormon: Score 3: Month 6 (n=29)0
Recormon: Score 5: Month 6 (n=29)0
Eprex: Score 1: Baseline (n=21)100.0
Eprex: Score 2: Baseline (n=21)0
Eprex: Score 4: Baseline (n=21)0
Eprex: Score 5: Baseline (n=21)0
Eprex: Score 1: Month 6 (n=19)94.7
Eprex: Score 2: Month 6 (n=19)0
Eprex: Score 3: Month 6 (n=19)0
Eprex: Score 5: Month 6 (n=19)5.3
Aranesp: Score 1: Baseline (n=40)90.0
Aranesp: Score 2: Baseline (n=40)2.5
Aranesp: Score 4: Baseline (n=40)2.5
Aranesp: Score 5: Baseline (n=40)5.0
Aranesp: Score 1: Month 6 (n=37)94.6
Aranesp: Score 2: Month 6 (n=37)0
Aranesp: Score 3: Month 6 (n=37)5.4
Aranesp: Score 5: Month 6 (n=37)0
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Convenience of Syringe Usage
percentage of participantsChronic Renal Anemia Participants
Score 1: Baseline (n=196)2.0 (0.6 to 5.1)
Score 3: Baseline (n=196)2.6 (0.8 to 5.9)
Score 4: Baseline (n=196)6.6 (3.6 to 11.1)
Score 5: Baseline (n=196)88.8 (83.5 to 92.8)
Score 1: Month 6 (n=151)0.7 (0 to 3.6)
Score 3: Month 6 (n=151)2.0 (0.4 to 5.7)
Score 4: Month 6 (n=151)4.0 (1.5 to 8.4)
Score 5: Month 6 (n=151)93.4 (88.2 to 96.8)
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Convenience of Syringe Usage by ESA Type
percentage of participantsChronic Renal Anemia Participants
Mircera: Score 1: Baseline (n=101)4.0
Mircera: Score 3: Baseline (n=101)1.0
Mircera: Score 4: Baseline (n=101)5.0
Mircera: Score 5: Baseline (n=101)90.1
Mircera: Score 1: Month 6 (n=66)0
Mircera: Score 3: Month 6 (n=66)0
Mircera: Score 4: Month 6 (n=66)1.5
Mircera: Score 5: Month 6 (n=66)98.5
Recormon: Score 1: Baseline (n=34)0
Recormon: Score 3: Baseline (n=34)2.9
Recormon: Score 4: Baseline (n=34)11.8
Recormon: Score 5: Baseline (n=34)85.3
Recormon: Score 1: Month 6 (n=29)0
Recormon: Score 3: Month 6 (n=29)3.4
Recormon: Score 4: Month 6 (n=29)6.9
Recormon: Score 5: Month 6 (n=29)89.7
Eprex: Score 1: Baseline (n=21)0
Eprex: Score 3: Baseline (n=21)0
Eprex: Score 4: Baseline (n=21)0
Eprex: Score 5: Baseline (n=21)100.0
Eprex: Score 1: Month 6 (n=19)5.3
Eprex: Score 3: Month 6 (n=19)5.3
Eprex: Score 4: Month 6 (n=19)0
Eprex: Score 5: Month 6 (n=19)89.5
Aranesp: Score 1: Baseline (n=40)0
Aranesp: Score 3: Baseline (n=40)7.5
Aranesp: Score 4: Baseline (n=40)10.0
Aranesp: Score 5: Baseline (n=40)82.5
Aranesp: Score 1: Month 6 (n=37)0
Aranesp: Score 3: Month 6 (n=37)2.7
Aranesp: Score 4: Month 6 (n=37)8.1
Aranesp: Score 5: Month 6 (n=37)89.2
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Injection Site Pain
percentage of participantsChronic Renal Anemia Participants
Score 1: Baseline (n=196)88.8 (83.5 to 92.8)
Score 1: Month 6 (n=151)92.1 (86.5 to 95.8)
Score 2: Baseline (n=196)8.2 (4.7 to 12.9)
Score 2: Month 6 (n=151)6.0 (2.8 to 11.0)
Score 3: Baseline (n=196)1.5 (0.3 to 4.4)
Score 3: Month 6 (n=151)1.3 (0.2 to 4.7)
Score 4: Baseline (n=196)0.5 (0 to 2.8)
Score 4: Month 6 (n=151)0.7 (0 to 3.6)
Score 5: Baseline (n=196)1.0 (0.1 to 3.6)
Score 5: Month 6 (n=151)0 (0 to 0)
SecondaryPercentage 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.

Time frame:
Baseline, Month 6
Reported as:
Number · percentage of participants
Percentage of Participants by Injection Site Pain by ESA Type
percentage of participantsChronic Renal Anemia Participants
Mircera: Score 1: Baseline (n=101)92.1
Mircera: Score 2: Baseline (n=101)6.9
Mircera: Score 3: Baseline (n=101)1.0
Mircera: Score 4: Baseline (n=101)0
Mircera: Score 5: Baseline (n=101)0
Mircera: Score 1: Month 6 (n=66)97.0
Mircera: Score 2: Month 6 (n=66)3.0
Mircera: Score 3: Month 6 (n=66)0
Mircera: Score 4: Month 6 (n=66)0
Recormon: Score 1: Baseline (n=34)91.2
Recormon: Score 2: Baseline (n=345.9
Recormon: Score 3: Baseline (n=34)2.9
Recormon: Score 4: Baseline (n=34)0
Recormon: Score 5: Baseline (n=34)0
Recormon: Score 1: Month 6 (n=29)96.6
Recormon: Score 2: Month 6 (n=29)3.4
Recormon: Score 3: Month 6 (n=29)0
Recormon: Score 4: Month 6 (n=29)0
Eprex: Score 1: Baseline (n=21)71.4
Eprex: Score 2: Baseline (n=21)23.8
Eprex: Score 3: Baseline (n=21)4.8
Eprex: Score 4: Baseline (n=21)0
Eprex: Score 5: Baseline (n=21)0
Eprex: Score 1: Month 6 (n=19)84.2
Eprex: Score 2: Month 6 (n=19)15.8
Eprex: Score 3: Month 6 (n=19)0
Eprex: Score 4: Month 6 (n=19)0
Aranesp: Score 1: Baseline (n=40)87.5
Aranesp: Score 2: Baseline (n=40)5.0
Aranesp: Score 3: Baseline (n=40)0
Aranesp: Score 4: Baseline (n=40)2.5
Aranesp: Score 5: Baseline (n=40)5.0
Aranesp: Score 1: Month 6 (n=37)83.8
Aranesp: Score 2: Month 6 (n=37)8.1
Aranesp: Score 3: Month 6 (n=37)5.4
Aranesp: Score 4: Month 6 (n=37)2.7

Adverse events

Collected over From Baseline up to Month 6. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chronic Renal Anemia Participants—3/196 (1.5%)—
Most frequent serious events
Most frequent serious events
EventChronic Renal Anemia Participants
Upper gastrointestinal haemorrhageGastrointestinal disorders1/196
Cardiac failure congestiveCardiac disorders1/196
Chronic kidney diseaseRenal and urinary disorders1/196
DeathGeneral disorders1/196

Baseline characteristics

All enrolled participants

Age, Continuous
Age, Continuous(years)Chronic Renal Anemia Participants
Mean74.6 ± 10.6
Sex: Female, Male
Sex: Female, Male(Participants)Chronic Renal Anemia Participants
Female85
Male111
08

Study locations

7 sites
  • Clalit Carmiel
    Carmiel, Israel
  • Clalit- New Savyon Clinic
    Ganey Tikva, Israel
  • Clalit - Diabetic HaMoshava South Clinic
    Jerusalem, Israel
  • Clalit - Professional Clinic, Zvulun
    Kiryat Bialik, Israel
  • Kaplan Medical Center; Nephrology and Hypertension Services
    Rehovot, 76100, Israel
  • Clalit- Migdal HaMea Clinic, Tel Aviv
    Tel Aviv, Israel
  • Clalit Ben-Gurion
    Upper Nazareth, Israel
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02238067
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 12, 2014
Start date
Sep 2011
Primary completion
Aug 2013
Completion
Aug 2013
Results posted
Nov 6, 2016
Last update
Mar 24, 2017

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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