the Effects of Different Treatment Schemes on Cognitive Function of Patients With Idiopathic Membranous Nephropathy
- Sponsor
- Beijing Friendship Hospital
- Study ID
- NCT06245707
- Status
- Unknown
Conditions
- Idiopathic Membranous Nephropathy
- Mild Cognitive Impairment
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- prednisone,methylprednisone and cyclophosphamide — DRUGIn the first month, methylprednisolone 500mg/d was given intravenously for 3 days, and then prednisone 0.5 mg/(kg d) \* for 27 days. Oral cyclophosphamide 2.0 mg/(kg d) \* 30 days in the second month. After that, the first month and the second month plan were repeated twice.
- Rituximab — DRUGThe dosage of rituximab depends on peripheral blood B cells. After the treatment of rituximab, the peripheral blood B cells were in a clear state and then stopped. After monitoring the recovery of B cells, additional doses were given.
Study Details
This study intends to apply prospective, open, single-center, randomized controlled study to evaluate the cognitive status of patients with Idiopathic membranous nephropathy and the influence of different treatment schemes on the cognitive status of patients with Idiopathic membranous nephropathy, and explore the possible pathophysiological mechanism by using brain magnetic resonance imaging technology.
Key Dates
- Start date
- Oct 1, 2023
- Status verified
- Sep 2023
- Primary completion
- Sep 30, 2025
- Completion
- Sep 30, 2025
Study Design
- Enrollment
- 2 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ponticelli groupPatients with idiopathic membranous nephropathy were treated with Ponticelli protocol,that is alternating prednisone or methylprednisone -cyclophosphamide every other month
- Experimental: Rituximab groupPatients with idiopathic membranous nephropathy were treated with Rituximab.The specific dosage of rituximab depends on the guidance of peripheral blood B cells.
Primary Outcome Measure
The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA) [ Time Frame: enrollment, half a year after treatment and one year after treatment. ]
Central Contacts
- Wenhu Liu15110124629
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