N/A
N=196
Survey on Anemia Therapy in Participants With Chronic Kidney Disease (CKD) Not on Dialysis
Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02238067 ↗Enrolled (actual)
196
Serious AEs
1.5%
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Participants by ESA Types at Baseline — 51.5; 17.3; 10.7; 20.4 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ESA (Drug); Satisfaction Survey Questionnaire (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants by ESA Types at Baseline |
51.5; 17.3; 10.7; 20.4 | — |
| PRIMARY Percentage of Participants by ESA Types at Month 6 |
43.7; 19.2; 12.6; 24.5 | — |
| PRIMARY Percentage of Participants by Frequency of ESA Use at Baseline |
2.6; 7.2; 14.9; 26.2; 38.5; 10.8 | — |
| PRIMARY Percentage of Participants by Frequency of ESA Use at Month 6 |
1.3; 4.0; 15.9; 25.2; 39.1; 14.6 | — |
| PRIMARY Percentage of Participants by Frequency and Types of ESA Used at Baseline |
2.0; 4.0; 1.0; 26.0; 67.0; 0 | — |
| PRIMARY Percentage of Participants by Frequency and Types of ESA Used at Month 6 |
1.5; 1.5; 0; 18.2; 71.2; 7.6 | — |
| SECONDARY Percentage of Participants by Different CKD Stages |
2.0; 1.3; 10.2; 13.9; 37.8; 41.7 | — |
| SECONDARY Percentage of Participants by Different Injection Administration Modes |
18.4; 23.2; 16.8; 17.9; 3.6; 3.3 | — |
| SECONDARY Percentage of Participants With Interest in Learning to Inject Independently |
6.3; 4.3 | — |
| SECONDARY Percentage of Participants by Need for Improvement in Treatment Frequency |
94.9; 96.0; 1.5; 1.3; 1.5; 1.3 | — |
| SECONDARY Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type |
98.0; 2.0; 0; 0; 0; 94.1 | — |
| SECONDARY Percentage of Participants by Preferred Treatment Frequency |
63.8; 49.0; 17.3; 23.8; 12.8; 17.2 | — |
| SECONDARY Percentage of Participants by Preferred Treatment Frequency by ESA Type |
83.2; 75.8; 14.9; 15.2; 1.0; 3.0 | — |
| SECONDARY Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency |
80.0; 50.0; 28.6; 0; 27.6; 12.5 | — |
| SECONDARY Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements |
96.4; 97.4; 1.0; 0.7; 0; 1.3 | — |
| SECONDARY Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types |
97.0; 1.0; 0; 2.0; 100.0; 0 | — |
| SECONDARY Percentage of Participants by Convenience of Syringe Usage |
2.0; 2.6; 6.6; 88.8; 0.7; 2.0 | — |
| SECONDARY Percentage of Participants by Convenience of Syringe Usage by ESA Type |
4.0; 1.0; 5.0; 90.1; 0; 0 | — |
| SECONDARY Percentage of Participants by Injection Site Pain |
88.8; 92.1; 8.2; 6.0; 1.5; 1.3 | — |
| SECONDARY Percentage of Participants by Injection Site Pain by ESA Type |
92.1; 6.9; 1.0; 0; 0; 97.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02238067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.