Higher hemoglobin levels using darbepoetin alfa and kidney outcomes in advanced chronic kidney disease without diabetes: a prespecified secondary analysis of the PREDICT trial.
Clin Exp Nephrol
; 27(9): 757-766, 2023 Sep.
Article
en En
| MEDLINE
| ID: mdl-37289335
ABSTRACT
BACKGROUND:
In the primary analysis of the PREDICT trial, a higher hemoglobin target (11-13 g/dl) with darbepoetin alfa did not improve renal outcomes compared with a lower hemoglobin target (9-11 g/dl) in advanced chronic kidney disease (CKD) without diabetes. Prespecified secondary analyses were performed to further study the effects of targeting higher hemoglobin levels on renal outcomes.METHODS:
Patients with an estimated glomerular filtration rate (eGFR) 8-20 ml/min/1.73 m2 without diabetes were randomly assigned 11 to the high- and low-hemoglobin groups. The differences between the groups were evaluated for the following endpoints and cohort sets eGFR and proteinuria slopes, assessed using a mixed-effects model in the full analysis set and the per-protocol set that excluded patients with off-target hemoglobin levels; the primary endpoint of composite renal outcome, evaluated in the per-protocol set using the Cox model.RESULTS:
In the full analysis set (high hemoglobin, n = 239; low hemoglobin, n = 240), eGFR and proteinuria slopes were not significantly different between the groups. In the per-protocol set (high hemoglobin, n = 136; low hemoglobin, n = 171), the high-hemoglobin group was associated with reduced composite renal outcome (adjusted hazard ratio 0.64; 95% confidence interval 0.43-0.96) and an improved eGFR slope (coefficient + 1.00 ml/min/1.73 m2/year; 95% confidence interval 0.38-1.63), while the proteinuria slope did not differ between the groups.CONCLUSIONS:
In the per-protocol set, the high-hemoglobin group demonstrated better kidney outcomes than the low-hemoglobin group, suggesting a potential benefit of maintaining higher hemoglobin levels in patients with advanced CKD without diabetes. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov (identifier NCT01581073).Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Diabetes Mellitus
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Insuficiencia Renal Crónica
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Anemia
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Neoplasias
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
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Guideline
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Prognostic_studies
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Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Clin Exp Nephrol
Asunto de la revista:
NEFROLOGIA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Japón