N/A
N=441
Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations
ANEMIA
Bottom Line
View on ClinicalTrials.gov: NCT01903148 ↗Enrolled (actual)
441
Serious AEs
0.4%
Results posted
Jan 2014
Primary outcome: Primary: % Patients Achieving Target Hemoglobin Levels — 42.5; 35.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Senefro
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Patients Achieving Target Hemoglobin Levels |
42.5; 35.3 | — |
| SECONDARY Hemoglobin Levels Per Type of Patients |
11.6; 11.5; 11.4; 11.1; 11.4; 11.5 | — |
| SECONDARY Patients With Hb>12 |
52; 71 | — |
| SECONDARY % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy |
74.1; 83.4; 19.6; 13.1; 2.1; 1.7 | — |
| SECONDARY Iron Treatment |
68; 175 | — |
| SECONDARY Patients With Hb<11 |
38; 98 | — |
Summary
The purpose of this study is to evaluate the impact of the last recommendations of the European Anemia Working Group ERBP in the anemia management in the achievement of the therapeutic goal of Hb 11-12 g/dL.
Eligibility Criteria
Inclusion Criteria
- Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
- Patients starting anemia treatment (naïve) after six months of the last recommendations of the European Anemia Working Group ERBP (January 2011).
- Patients in treatment who changed from previous ESA treatment since January 2011 (converted patients
Exclusion Criteria
- Patients in Erythropoiesis Stimulating Agents (ESA) dose adjustment period.
- Kidney transplant patients.
Data sourced from ClinicalTrials.gov (NCT01903148). 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.