ANEMIA
Conditions
Keywords
ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS
Brief 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.
Interventions
None listed
Sponsors
Fundación Senefro
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Patients Achieving Target Hemoglobin Levels | 1 day because is a crosssectional study with only a visit | % patients with Hb levels between 11-12 mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Levels Per Type of Patients | 1 day | levels Hb and type of patients |
| Patients With Hb>12 | 1 day | — |
| % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | 1 day | know the treatments ESA for maintenance of hb levels |
| Iron Treatment | 1 day | Patients with supplementary Iron treatment to ESA |
| Patients With Hb<11 | 1 day | — |
Countries
Spain
Participant flow
Recruitment details
Nephrology Units of 30 Spanish hospitals.
Pre-assignment details
14 patients were excluded because they didn't fulfill the eligibility criteria
Participants by arm
| Arm | Count |
|---|---|
| Converted Patients Patients in treatment who changed from previous ESA treatment since January 2011 | 143 |
| Naïve Patients Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011) | 298 |
| Total | 441 |
Baseline characteristics
| Characteristic | Converted Patients | Naïve Patients | Total |
|---|---|---|---|
| Age Continuous | 73.5 years STANDARD_DEVIATION 13.9 | 72.9 years STANDARD_DEVIATION 12.5 | 73.1 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 77 Participants | 152 Participants | 229 Participants |
| Sex: Female, Male Male | 66 Participants | 146 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 143 | 1 / 298 |
| serious Total, serious adverse events | 1 / 143 | 1 / 298 |
Outcome results
Primary
% Patients Achieving Target Hemoglobin Levels
% patients with Hb levels between 11-12 mg/dl
Time frame: 1 day because is a crosssectional study with only a visit
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Converted Patients | % Patients Achieving Target Hemoglobin Levels | 42.5 percentage of participants | 1.3 |
| Naïve Patients | % Patients Achieving Target Hemoglobin Levels | 35.3 percentage of participants | 1.3 |
Secondary
Hemoglobin Levels Per Type of Patients
levels Hb and type of patients
Time frame: 1 day
Population: n represents the number of participants analyzed for each category respectively (converted patients, naïve patients)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels in non diabetics patients, n=79, 163 | 11.6 mg/dl | Standard Deviation 1.2 |
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels in diabetics patients, n=64, 135 | 11.4 mg/dl | Standard Deviation 1.3 |
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients non cardiovasdisease, n=76, 151 | 11.4 mg/dl | Standard Deviation 1.2 |
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients cardiovasculardisease, n=67,147 | 11.7 mg/dl | Standard Deviation 1.4 |
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients noncerebrovadisease, n=125, 265 | 11.6 mg/dl | Standard Deviation 1.2 |
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients with cerebrovadisease n=18, 33 | 11.4 mg/dl | Standard Deviation 1.7 |
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients non cancer, n=129,257 | 11.5 mg/dl | Standard Deviation 1.3 |
| Converted Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients with cancer n=14, 41 | 11.6 mg/dl | Standard Deviation 1.2 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients with cancer n=14, 41 | 11.3 mg/dl | Standard Deviation 1.2 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels in non diabetics patients, n=79, 163 | 11.5 mg/dl | Standard Deviation 1.2 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients noncerebrovadisease, n=125, 265 | 11.3 mg/dl | Standard Deviation 1.3 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels in diabetics patients, n=64, 135 | 11.1 mg/dl | Standard Deviation 1.3 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients non cancer, n=129,257 | 11.3 mg/dl | Standard Deviation 1.3 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients non cardiovasdisease, n=76, 151 | 11.5 mg/dl | Standard Deviation 1.3 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients with cerebrovadisease n=18, 33 | 11.4 mg/dl | Standard Deviation 1.1 |
| Naïve Patients | Hemoglobin Levels Per Type of Patients | Hb levels patients cardiovasculardisease, n=67,147 | 11.2 mg/dl | Standard Deviation 1.2 |
Secondary
Iron Treatment
Patients with supplementary Iron treatment to ESA
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Converted Patients | Iron Treatment | 68 participants |
| Naïve Patients | Iron Treatment | 175 participants |
Secondary
% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
know the treatments ESA for maintenance of hb levels
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Converted Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Mircera | 74.1 percentage of participants |
| Converted Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Darbepoetin | 19.6 percentage of participants |
| Converted Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Epoetin alfa | 2.1 percentage of participants |
| Converted Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Epoetin beta | 4.2 percentage of participants |
| Naïve Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Epoetin beta | 1.7 percentage of participants |
| Naïve Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Mircera | 83.4 percentage of participants |
| Naïve Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Epoetin alfa | 1.7 percentage of participants |
| Naïve Patients | % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | Darbepoetin | 13.1 percentage of participants |
Secondary
Patients With Hb<11
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Converted Patients | Patients With Hb<11 | 38 participants |
| Naïve Patients | Patients With Hb<11 | 98 participants |
Secondary
Patients With Hb>12
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Converted Patients | Patients With Hb>12 | 52 participants |
| Naïve Patients | Patients With Hb>12 | 71 participants |