NCT03864250

Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy

Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This random, open, control and multicenter clinical trial mainly aims to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN).

Conditions

• Tacrolimus
• Idiopathic Membranous Nephropathy
• Clinical Trial

Interventions

Type	Name	Description
DRUG	Tacrolimus	The initial dose of TAC is 0.05-0.1 mg/kg/d, taking 2 hours before and after meals. The interval is strictly 12 hours. The blood concentration is measured after taking the drug. According to the concentration of blood drug valley, the dose of tacrolimus (blood concentration of ≤10ng/ml) is adjusted. If the blood drug concentration is low, the drug dose (≤0.1mg/kg/d) is increased accordingly. After 6 months of treatment, the drug is discontinued. The TAC dose is maintained at the original dose after 6 months of treatment with complete or partial remission of urinary protein until the end of the 48-week trial.
DRUG	Prednisone	The initial dose of prednisone is 0.5 mg/kg/d orally (maximum dose 40 mg/d), and after 8-12 weeks, the dose was gradually reduced until discontinuation. TAC treatment is given at the same time (the treatment plan is the same as the experimental group).

Timeline

• Start date: 2018-11-26
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2019-03-06
• Last updated: 2019-06-25

Locations

1 site across 1 country: China