Table 3.
Phase 2 randomized trials with HCO-HD in cast nephropathy
| Characteristics | EuLITE | MYRE |
|---|---|---|
| Demographics Number of patients Female |
43 in the HCO group, 47 in the HF-HD group 40% in the HCO group, 47% in the HF-HD group |
46 in the HCO group, 48 in the HF-HD group 50% in the HCO group, 40% in the HF-HD group |
| Multiple myeloma LC only MM Cast nephropathy chemotherapy |
53% in the HCO group, 51% in the HF-HD group Biopsy-proven Bortezomib (1 mg/m2 on days 1, 4, 8, 11 and 21), doxorubicin and dexamethasone |
50% in the HCO group; 46% in the HF-HD group Biopsy-proven Bortezomib (1 × 3 mg/m2 on days 1, 4, 8 and 11) and dexamethasone |
| Intervention: comparison with conventional therapy with HF-HD | Two 1 × 1 m2 filter in series (HCO1100; Gambro); 6-h session at baseline, then 8-h sessions on days 2, 3, 5, 6, 7, 9 and 10; from day 12, 8 h sessions on alternate days, reducing to 6-h sessions on alternate days from day 21; 60 g albumin was perfused at each session | Single membrane 2 × 1 m2 dialyser (Theralite; Gambro); 5 h per session; eight sessions for 10 days, and thereafter three sessions per week if needed, until completion of three cycles of chemotherapy 5 h/session; if serum albumin is <25 g/L before HD, 20 g albumin was perfused after dialysis |
| Primary outcome: Discontinuation of dialysis at3 months |
56% in the HCO group; 51% in the HF-HD group; P = 0.81 |
41.3% in the HCO group; 33.3% in the HF-HD group; P = 0.42 |
| Secondary outcomes: Discontinuation of dialysis at6 months Discontinuation of dialysis at12 months Haematologic response at6 months Haematologic response at12 months |
58% in the HCO group; 66% in the HF-HD group; P = 0.76 58% in the HCO group; 66% in the HF-HD group; P = 0.76 67% in the HCO group; 73% in the HF-HD group; P = 0.46 42% in the HCO group; 68% in the HF-HD group; P = 0.02 |
56.5% in the HCO group; 35.4% in the HF-HD; P = 0.04 60.9% in the HCO group; 37.5% in the HF-HD group; P = 0.02 78.3% in the HCO group; 60.4% in the HF-HD group; P = 0.06 Not reported |
| Mortality | At 24 months: 37% in the HCO group; 19% in the HF-HD group; P = 0.03 | At 12 months: 20% in the HCO group; 21% in the HF-HD group; P = 0.46 |