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

January 29, 2024 updated by: Beijing Friendship Hospital

To Evaluate the Effects of Different Treatment Schemes on Cognitive Function of Patients With Idiopathic Membranous Nephropathy and Explore the Possible Mechanism by Using Functional Magnetic Resonance Imaging (fMRI)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friedship Hospital
        • Contact:
        • Sub-Investigator:
          • Zongli Diao, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ponticelli group
Patients with idiopathic membranous nephropathy were treated with Ponticelli protocol,that is alternating prednisone or methylprednisone -cyclophosphamide every other month
Drug: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
enrollment, half a year after treatment and one year after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain magnetic resonance high-resolution structural imaging was performed to observe the changes of brain structure
Time Frame: 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).
enrollment, half a year after treatment and one year after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Jia Wang, Student

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-P2-233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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