Table 1.
Participants timeline
| Study period |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Enrolment | Allocation and treatment | Follow-up |
Close-out | |||||||
| Timepoint | −1 | 0 | t1 | t3 | t6 | t9 | t12 | t15 | t18 | t24 |
| ENROLMENT | ||||||||||
| Relevant medical history | X | |||||||||
| Eligibility screen | X | |||||||||
| Project illustration | X | |||||||||
| Informed consent | X | |||||||||
| Instruction about immunosuppressive drugs tapering | X | X | ||||||||
| Allocation | X | |||||||||
| INTERVENTIONS | ||||||||||
| Ofatumumab/rituximab administration | X | |||||||||
| ASSESSMENTS | ||||||||||
| Dosage on 24-hours urine collection | X | X | X | X | X | X | X | X | X | X |
| Physical examination and vital signs | X | X | X | X | X | X | X | X | X | X |
| Haematology and biochemistry (complete blood count, kidney function, plasma proteins immunoglobulins, lipid status—cholesterol and triglycerides—, albumin, lymphocyte subpopulations—for CD20 lymphocytes B count) | X | X | X | X | X | X | X | X | X | X |
| Adverse events data records | X | X | X | X | X | X | X | X | X | |