Phase 3
Completed N=603
A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia
Source: ClinicalTrials.gov NCT00321919 ↗Enrolled (actual)
603
Serious AEs
50.3%
Results posted
May 2016
Primary outcomePrimary: Median Time to First Cardiovascular Event — NA; NA days — p=0.2036
◆ Published Evidence
Highly cited
2,096citations · ~105 / year
Normalization of hemoglobin level in patients with chronic kidney disease and anemia.
Summary
This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.
Linked Publications (3)
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Normalization of hemoglobin level in patients with chronic kidney disease and anemia.
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Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
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Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to First Cardiovascular Event |
NA; NA | 0.2036 |
| SECONDARY Median Time to Death Due to Cardiovascular Events |
NA; NA | 0.4833 |
| SECONDARY Number of Participants Who Died Due to Cardiovascular Events |
8; 6; 1; 2; 1; 2 | — |
| SECONDARY Median Time to Death Due to All Causes |
NA; NA | 0.1391 |
| SECONDARY Number of Participants Who Died Due to All Causes |
31; 21; 4; 2; 2; 2 | — |
| SECONDARY Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL) |
49; 42; 7; 4; 7; 7 | — |
| SECONDARY Median Time to First Cardiovascular Intervention |
NA; NA | 0.4985 |
| SECONDARY Total Number of Cardiovascular Intervention |
21; 18 | — |
| SECONDARY Median Time to First Hospitalization Due to Cardiovascular Events |
NA; NA | 0.3419 |
| SECONDARY Duration of Hospitalization for Cardiovascular Events |
33.0; 28.2 | — |
| SECONDARY Mean Change From Baseline in Left Ventricular Mass Index (LVMI) |
120.32; 117.97; -5.06; -2.87; -6.58; -7.59 | — |
| SECONDARY Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS) |
81.31; 81.95; -0.08; 0.08; -0.47; -0.23 | — |
| SECONDARY Mean Change From Baseline in Left Ventricular Volume (LV Volume ) |
67.73; 65.11; -2.83; 3.15; -0.69; 2.62 | — |
| SECONDARY Mean Values of Echocardiography Parameters |
5.05; 4.91; 4.93; 4.94; 4.95; 4.93 | — |
| SECONDARY Mean Values of Body Surface Area |
1.83; 1.79; 1.83; 1.77; 1.82; 1.77 | — |
| SECONDARY Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire |
4.1; -0.1; 2.3; -1.9; 2.7; -2.1 | 0.0029 sig |
| SECONDARY Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs |
287; 282; 201; 204; 183; 180 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
5; 0; 13; 15; 140; 128 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
Exclusion Criteria
- women who are pregnant or lactating;
- previous treatment with erythropoietin or other erythropoietic substance;
- blood transfusion within the last 3 months;
- need for dialysis expected in the next 6 months;
- administration of another investigational drug within 30 days preceding study start, or during the study.
Data sourced from ClinicalTrials.gov (NCT00321919) and the linked publication. 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. Informational only — not medical advice.