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

NCT06245707 | Unknown

• 1 other identifier: 2023-P2-233
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Idiopathic Membranous Nephropathy

Outcome Measures

Primary Outcomes (1)

• The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)

  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 Outcomes (1)

• 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.

Study Arms (2)

Ponticelli group

EXPERIMENTAL

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

Rituximab group

EXPERIMENTAL

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

Interventions

prednisone,methylprednisone and cyclophosphamide 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.

Ponticelli group

Rituximab 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.

Rituximab group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friedship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Glomerulonephritis, Membranous

Interventions

Prednisone; Cyclophosphamide; Rituximab

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jia Wang

  Student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhu Liu

CONTACT

15110124629; wenhuliu@mail.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: February 7, 2024
• Study Start: October 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 7, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)