| Methods |
Prospective, multicenter, open‐label, randomized, controlled study Study length: 6 weeks |
| Participants |
Experimental arm: ESAs + IV iron dextran (bolus): enrolled 37, analyzed 37 Control arm: ESAs only: enrolled 36, analyzed 36 |
| Interventions |
Experimental arm: ESAs + IV iron dextran 100 mg bolus at each visit Control arm: ESAs only: rHuEPO 40,000 U SC (dose escalation or reduction was not permitted) |
| Outcomes |
|
| Notes |
Hematopoietic response defined as increase in Hb level of ≥ 2 g/dL or achievement of Hb level of ≥ 12 g/dL without transfusion during study. The number of participants "receiving transfusions" was reported (no separate reporting of RBCs versus other types of transfusions). QOL was measured using: LASA, ADL, and overall QOL index. The total dose of iron dextran was calculated using the formula to reach a desired Hb level of 140 g/L: dose (mL)0.0442 (desired Hb ‐ observed Hb) x LBW(0.26LBW) where LBW is the participant’s lean body weight in kilograms. All participants received iron dextran as INFeD (Watson Pharmaceuticals, Morristown, NJ), except for 2 participants who received iron dextran as Dexferrum (American Regent Laboratories, Shirley, NY) during a brief period when the first formulation was not available. Participants randomly assigned to 100 mg bolus injections received a 25 mg test dose of iron dextran by IV push over 1 to 2 minutes, followed by a 75 mg bolus injection before the first 3 epoetin alfa doses (i.e. for the first 3 weeks of the study). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Trial authors described the study as “randomized controlled” and reported that “patients were centrally randomly assigned…,” however this information is insufficient to permit judgment about the sequence generation process because details of how sequence was generated are not provided |
| Allocation concealment (selection bias) |
Low risk |
“patients were centrally randomly assigned” |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
There was no blinding (study described as “open‐label”), yet outcome measurement was likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Trial authors reported that efficacy data were analyzed according to the "modified ITT principle." Withdrawals and dropouts were described adequately |
| Selective reporting (reporting bias) |
Low risk |
One outcome of interest in the review (RBC transfusion) was not reported, however it was reported that the study was not powered to detect differences in RBC transfusion requirements |
| Other bias |
Low risk |
Prespecified values of sample size, alpha and beta errors and delta were provided |
