Prognostic Model of TAC in the Treatment of MN

NCT ID: NCT05667922

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (IMN) under the treatment of tacrolimus. The main questions it aims to answer are:

• to explore the factors that can predict the prognosis difference in patients with IMN under the treatment of tacrolimus
• to establish a clinical prediction model and verify it to provide a reference for the early Participants will receive standard the treatment of tacrolimus treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. Blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy.

Researchers will compare [remission group and non-remission group] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.

Conditions

Idiopathic Membranous Nephropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Remission

Tacrolimus

Intervention Type: DRUG

0.05-0.10mg/kg/d, twice orally, with an interval of 12h. The drug valley concentration is 5-10ng/ml, which will be gradually reduced to a low dose after it is effective.

Non-remission

Tacrolimus

Intervention Type: DRUG

0.05-0.10mg/kg/d, twice orally, with an interval of 12h. The drug valley concentration is 5-10ng/ml, which will be gradually reduced to a low dose after it is effective.

Interventions

Tacrolimus

0.05-0.10mg/kg/d, twice orally, with an interval of 12h. The drug valley concentration is 5-10ng/ml, which will be gradually reduced to a low dose after it is effective.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase A2 receptor (PLA2R) antibody positive by renal puncture biopsy, and the clinical data were complete;

2. According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss.

3. In general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others;

4. Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.

Exclusion Criteria

1. There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;

2. At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;

3. The medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases;

4. During follow-up, the patient cannot actively cooperate or accurately understand and express.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zunsong Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IMN-TAC

Identifier Type: -

Identifier Source: org_study_id