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

NCT ID: NCT06245707

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment Idiopathic Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ponticelli group

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

Group Type EXPERIMENTAL

prednisone,methylprednisone and cyclophosphamide

Intervention Type DRUG

In 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 group

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

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

The 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.

Interventions

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prednisone,methylprednisone and cyclophosphamide

In 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.

Intervention Type DRUG

Rituximab

The 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jia Wang

Role: PRINCIPAL_INVESTIGATOR

Student

Locations

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Beijing Friedship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhu Liu

Role: CONTACT

15110124629

Facility Contacts

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Wenhu Liu, Doctor

Role: primary

+86-01-63139144

Other Identifiers

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2023-P2-233

Identifier Type: -

Identifier Source: org_study_id

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