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

Not Applicable

Recruiting

• Conditions: Idiopathic Membranous Nephropathy; Mild Cognitive Impairment
• Interventions: Drug: prednisone,methylprednisone and cyclophosphamide; Drug: Rituximab

• Registration Number: NCT06245707
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-25
• Study Start: 2023-10-01
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ponticelli group	prednisone,methylprednisone and cyclophosphamide	Patients with idiopathic membranous nephropathy were treated with Ponticelli protocol,that is alternating prednisone or methylprednisone -cyclophosphamide every other month
Rituximab group	Rituximab	Patients with idiopathic membranous nephropathy were treated with Rituximab.The specific dosage of rituximab depends on the guidance of peripheral blood B cells.

Primary Outcome Measures

Name	Time	Method
The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)	enrollment, half a year after treatment and one year after treatment.	The two groups of patients were given a quiet environment and completed the test within 10 minutes. The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA). The possible score was between 0 and 30. The higher the score, the better the cognitive state. We defined cognitive impairment as a total score of less than 26 for participants with high school education or below and less than 27 for participants with high school education or above, because the average score of MOCA varies according to the level of education

Secondary Outcome Measures

Name	Time	Method
Brain magnetic resonance high-resolution structural imaging was performed to observe the changes of brain structure	enrollment, half a year after treatment and one year after treatment.	All participants were examined with 3.0T MRI scanner (GE Healthcare, discovery mr750w, Milwaukee, WI), using quantitative techniques such as high-resolution structural magnetic resonance, resting state functional magnetic resonance and arteriovenous spin labeling imaging (ASL).

Trial Locations

Locations (1)

Beijing Friedship Hospital; 🇨🇳 Beijing, Beijing, China