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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Membranous Nephropathy
• Intervention / Treatment: Drug: glucocorticoid + tacrolimus

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remission	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.
Non-remission	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission	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.; 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.; Complete Remission of the State of MN: 24-h UP<0.5g, serum creatinine normal, plasma albumin ≥ 35g.	6 months

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, Membranous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Calcineurin Inhibitors; Tacrolimus; Glucocorticoids
• Other Study ID Numbers: IMN-GC/TAC

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: Yes
• Studies a U.S. FDA-regulated device product: No