Trial Outcomes & Findings for Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations (NCT NCT01903148)
NCT ID: NCT01903148
Last Updated: 2014-01-01
Results Overview
% patients with Hb levels between 11-12 mg/dl
Recruitment status
COMPLETED
Target enrollment
455 participants
Primary outcome timeframe
1 day because is a crosssectional study with only a visit
Results posted on
2014-01-01
Participant Flow
Nephrology Units of 30 Spanish hospitals.
14 patients were excluded because they didn't fulfill the eligibility criteria
Participant milestones
| Measure |
Patients With Anemia and CKD
Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
|
|---|---|
|
Overall Study
STARTED
|
441
|
|
Overall Study
COMPLETED
|
441
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations
Baseline characteristics by cohort
| Measure |
Converted Patients
n=143 Participants
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 Participants
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
73.5 years
STANDARD_DEVIATION 13.9 • n=93 Participants
|
72.9 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
73.1 years
STANDARD_DEVIATION 13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=93 Participants
|
152 Participants
n=4 Participants
|
229 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=93 Participants
|
146 Participants
n=4 Participants
|
212 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 day because is a crosssectional study with only a visit% patients with Hb levels between 11-12 mg/dl
Outcome measures
| Measure |
Converted Patients
n=143 Participants
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 Participants
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
% Patients Achieving Target Hemoglobin Levels
|
42.5 percentage of participants
1.3
|
35.3 percentage of participants
1.3
|
SECONDARY outcome
Timeframe: 1 dayPopulation: n represents the number of participants analyzed for each category respectively (converted patients, naïve patients)
levels Hb and type of patients
Outcome measures
| Measure |
Converted Patients
n=143 Participants
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 Participants
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
Hemoglobin Levels Per Type of Patients
Hb levels in non diabetics patients, n=79, 163
|
11.6 mg/dl
Standard Deviation 1.2
|
11.5 mg/dl
Standard Deviation 1.2
|
|
Hemoglobin Levels Per Type of Patients
Hb levels in diabetics patients, n=64, 135
|
11.4 mg/dl
Standard Deviation 1.3
|
11.1 mg/dl
Standard Deviation 1.3
|
|
Hemoglobin Levels Per Type of Patients
Hb levels patients non cardiovasdisease, n=76, 151
|
11.4 mg/dl
Standard Deviation 1.2
|
11.5 mg/dl
Standard Deviation 1.3
|
|
Hemoglobin Levels Per Type of Patients
Hb levels patients cardiovasculardisease, n=67,147
|
11.7 mg/dl
Standard Deviation 1.4
|
11.2 mg/dl
Standard Deviation 1.2
|
|
Hemoglobin Levels Per Type of Patients
Hb levels patients noncerebrovadisease, n=125, 265
|
11.6 mg/dl
Standard Deviation 1.2
|
11.3 mg/dl
Standard Deviation 1.3
|
|
Hemoglobin Levels Per Type of Patients
Hb levels patients with cerebrovadisease n=18, 33
|
11.4 mg/dl
Standard Deviation 1.7
|
11.4 mg/dl
Standard Deviation 1.1
|
|
Hemoglobin Levels Per Type of Patients
Hb levels patients non cancer, n=129,257
|
11.5 mg/dl
Standard Deviation 1.3
|
11.3 mg/dl
Standard Deviation 1.3
|
|
Hemoglobin Levels Per Type of Patients
Hb levels patients with cancer n=14, 41
|
11.6 mg/dl
Standard Deviation 1.2
|
11.3 mg/dl
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Converted Patients
n=143 Participants
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 Participants
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
Patients With Hb>12
|
52 participants
|
71 participants
|
SECONDARY outcome
Timeframe: 1 dayknow the treatments ESA for maintenance of hb levels
Outcome measures
| Measure |
Converted Patients
n=143 Participants
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 Participants
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
Mircera
|
74.1 percentage of participants
|
83.4 percentage of participants
|
|
% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
Darbepoetin
|
19.6 percentage of participants
|
13.1 percentage of participants
|
|
% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
Epoetin alfa
|
2.1 percentage of participants
|
1.7 percentage of participants
|
|
% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
Epoetin beta
|
4.2 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: 1 dayPatients with supplementary Iron treatment to ESA
Outcome measures
| Measure |
Converted Patients
n=143 Participants
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 Participants
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
Iron Treatment
|
68 participants
|
175 participants
|
SECONDARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Converted Patients
n=143 Participants
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 Participants
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
Patients With Hb<11
|
38 participants
|
98 participants
|
Adverse Events
Converted Patients
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Naïve Patients
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Converted Patients
n=143 participants at risk
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 participants at risk
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
Vascular disorders
Hipercalcemia
|
0.70%
1/143 • Number of events 1
|
0.00%
0/298
|
|
Cardiac disorders
Cardiac insufficiency left side
|
0.00%
0/143
|
0.34%
1/298 • Number of events 1
|
Other adverse events
| Measure |
Converted Patients
n=143 participants at risk
Patients in treatment who changed from previous ESA treatment since January 2011
|
Naïve Patients
n=298 participants at risk
Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
|
|---|---|---|
|
Cardiac disorders
Precordial pain
|
0.70%
1/143 • Number of events 1
|
0.00%
0/298
|
|
Cardiac disorders
auricular fibrilation
|
0.70%
1/143 • Number of events 1
|
0.00%
0/298
|
|
Renal and urinary disorders
Urinary infection
|
0.70%
1/143 • Number of events 1
|
0.00%
0/298
|
|
Renal and urinary disorders
orquiepididimitis
|
0.70%
1/143 • Number of events 1
|
0.00%
0/298
|
|
Renal and urinary disorders
Change sounds nefrostomia
|
0.00%
0/143
|
0.34%
1/298 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60