NCT05667896

Prognostic Model of GC/TAC in the Treatment of MN

Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Glucocorticoids Plus Tacrolimus

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 glucocorticoid + 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 glucocorticoid + tacrolimus * to establish a clinical prediction model and verify it to provide a reference for the early Participants will receive standard the treatment of glucocorticoid + 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

Interventions

Type	Name	Description
DRUG	glucocorticoid + tacrolimus	Prednisone 0.4-0.5mg/kg/d; Tacrolimus 0.05-0.10mg/kg/d, oral administration in two times, with an interval of 12h. The drug valley concentration is 5-10ng/ml, which will be gradually reduced to a low dose after it becomes effective.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2022-12-29
• Last updated: 2023-03-17

Regulatory

• FDA-regulated drug study