Prognostic Model of TAC in the Treatment of MN

NCT05667922 | Unknown FDA Drug

• 1 other identifier: IMN-TAC
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Remission

  1. None-Remission of the State of MN: 1)24-hour urin protein (24-h UP)\>3.5 g, or 24-h UP\<50% lower than the baseline, or serum creatinine increased by 50% compared with the baseline; 2) Renal function progress: Compared with the initial examination, estimated glomerular filtration rate (eGFR) progress is greater than or equal to 30%; 3) End stage renal disease: eGFR\<15ml/min, or renal replacement therapy. 2. Partial Remission of the State of MN: 24-h UP is 0.5-3.5 g, and 24-h UP is more than 50% lower than the baseline, serum creatinine is normal, and plasma albumin is ≥ 30 g. 3. Complete remission of the State of MN: 24-h UP\<0.5g, serum creatinine normal, plasma albumin ≥ 35g.

  6 months

Study Arms (2)

Remission

Drug: Tacrolimus

Non-remission

Drug: Tacrolimus

Interventions

Tacrolimus 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; Remission

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with idiopathic membranous nephropathy diagnosed at age 18-75 years

You may qualify if:

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

You may not qualify if:

• There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;
• At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;
• 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;
• During follow-up, the patient cannot actively cooperate or accurately understand and express.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

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)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 29, 2022
• Study Start: June 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share