the Effects of Different Treatment Schemes on Cognitive Function of Patients With Idiopathic Membranous Nephropathy

Capital Medical University

Status: Enrolling

Conditions: Mild Cognitive Impairment; Idiopathic Membranous Nephropathy

Treatments: Drug: prednisone,methylprednisone and cyclophosphamide; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT06245707

2023-P2-233

Details and patient eligibility

About

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.

Full description

Proteinuia is an independent risk factor for cognitive dysfunction and dementia. There is no relevant research on whether patients with Idiopathic membranous nephropathy with normal renal function are complicated with cognitive impairment. In the process of clinical diagnosis and treatment, it was observed that the cognitive function of patients with Idiopathic membranous nephropathy decreased significantly after treatment compared with that before treatment. However, there is no clinical study to confirm this phenomenon at present, and the causes of cognitive function damage are not clear. 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, so as to fill the research gap of clinical cognitive status of Idiopathic membranous nephropathy and provide theoretical basis for better clinical treatment scheme selection and prevention of cognitive impairment.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with nephrotic syndrome and normal renal function.
• Patients with idiopathic membranous nephropathy diagnosed by pathology.
• not received hormone or other immunosuppressive treatment in the past six months.

Exclusion criteria

• Unable to treat patients with hormones and immunosuppression.
• Patients with definite intracranial diseases such as previous cerebral infarction and cerebral hemorrhage;
• Patients who have been diagnosed with cognitive decline or dementia in the past;
• Patients with claustrophobia or have other contraindications for magnetic resonance imaging, such as pacemakers and metal foreign bodies in the body.
• Pregnant and lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Ponticelli group

Experimental group

Description:

Patients with idiopathic membranous nephropathy were treated with Ponticelli protocol,that is alternating prednisone or methylprednisone -cyclophosphamide every other month

Treatment:

Drug: prednisone,methylprednisone and cyclophosphamide

Rituximab group

Experimental group

Description:

Patients with idiopathic membranous nephropathy were treated with Rituximab.The specific dosage of rituximab depends on the guidance of peripheral blood B cells.

Treatment:

Drug: Rituximab