Methods |
Study design: RCT
Study duration: NS
|
Participants |
Setting: multicentre
Country: The Netherlands
Stage of CKD: eGFR 20 to 70 mL/min/1.73 m²
Number: epoetin beta (20), no treatment (13)
Median age, IQR (years): epoetin beta (77, 70 to 81), no treatment (72, 64 to 67 (error in paper))
Sex (M/F): epoetin beta (12/8), no treatment (9/4)
Other characteristics: cardiorenal syndrome with chronic heart failure, CKD and anaemia; anaemia was defined as Hb between 10.3 and 12.6 g/dL in men and between 10.3 and 11.9 g/dL in women
Exclusion criteria: Erythropoietic therapy within 6 months before randomisation; uncontrolled hypertension (SBP > 160 mm Hg; DBP > 100 mm Hg); uncontrolled diabetes (HbA1c > 8.0%); kidney transplantation; proteinuria > 3.5 g/L; acute kidney failure or rapidly progressive glomerulonephritis; hyperparathyroidism (PTH > 40 pmol/L); haemoglobinopathies; bleeding or haemolysis as a cause of anaemia; deficiency of iron; folate and/or vitamin B12; chronic inflammatory disease or clinically significant infection; haematological malignancy or solid tumour < 3 years ago
|
Interventions |
Treatment
Control
Iron supplementation
|
Outcomes |
Primary study outcome
Outcomes extracted for meta‐analysis
|
Notes |
Funding: F. Hoffman‐La Roche
Trials registration: NCT00356733
Contact with study authors for additional information: contacted, additional information provided by sponsor
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not described |
Allocation concealment (selection bias) |
Unclear risk |
Not described |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
"Open‐label randomised trial" |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Not described |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
Not described |
Selective reporting (reporting bias) |
Low risk |
Major cardiovascular outcomes available |
Other bias |
Low risk |
None apparent; |