Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy

NCT03864250 | Unknown DMC

• 1 other identifier: XH-19-002
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Complete remission rate of 24-hour urine protein

  The proportion of patients with complete remission of 24-hour urine protein in the total evaluated patients. Evaluation criteria of complete remission: post-therapy urine protein level is \<0.3g/24h.

  At week 48

Secondary Outcomes (3)

• Partial remission remission rate of 24-hour urine protein

  At week 48

• PLA2R antibody negative conversion rate

  At week 48

• Number of patients with adverse events

  Up to 48 weeks

Study Arms (2)

Tacrolimus monotherapy

EXPERIMENTAL

Drug: Tacrolimus

Tacrolimus combined with hormone therapy

ACTIVE COMPARATOR

Drug: Tacrolimus; Drug: Prednisone

Interventions

Tacrolimus DRUG

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.

Tacrolimus combined with hormone therapy; Tacrolimus monotherapy

Prednisone DRUG

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).

Tacrolimus combined with hormone therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 80 years;
• Those whose clinical manifestation and renal biopsy pathologic diagnosis are IMN (Stages I-IV) with secondary membranous nephropathy excluded;
• Those who meet any of the following high-risk IMN standards:
• Urinary protein\>8g/24h
• Serum albumin\<25g/l
• Serum PLA2R levels are 5 times higher than normal
• eGFR decline rate after confirmed IMN within 6-12 months is ≥30%
• Patients with serious complications: pulmonary embolism, lower extremity static Vein thrombosis/embolism, acute renal injury, etc.
• Those without reaching the above high-risk IMN standard, but their course of disease is \>6 months without spontaneous remission,and still present nephrotic syndrome;
• Patients who have signed the informed consent forms.

You may not qualify if:

• Those whose kidney pathological manifestation of interstitial fibrosis is \>30%;
• Those who are positive in active Hepatitis B (including HBsAg, HBeAg and HBcAb or HBsAg, HBeAb and HBC) or serological indexes (HBsAg or/and HBeAg or/and HBcAb) or infected with Hepatitis C, tuberculosis, cytomegalovirus, severe fungal infection, syphilis or HIV infection;
• Those who suffer from untreated active digestive tract ulcer within 3 months before random grouping;
• Those who suffer from uncured malignant tumor less than 5 years;
• Those who received glucocorticoids (prednisone or prednisolone), mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, tripterygium and other immunosuppressive agents for treatment within 3 months before screening;
• Those whose ALT, AST or total bilirubin content goes beyond 1.5 times above normal upper limit;
• Those who suffer from combined critical complications such as serious infection or other severe organ disease or dysfunction;
• Pregnant or lactating women;
• Those who are known to be allergic to drugs under trial or relevant products;
• The patients who cannot comply with the research proposal as determined by the supervising physician.
• Exit criteria
• Those with incomplete or partial relieved proteinuria for 6 months after treatment;
• Patients or their legal guardians voluntarily requests to withdraw;
• Those who need to take medications prohibited by the trail;
• Those with poor compliance or stopping the drug for over 2 weeks;

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Xinhua Hospital affliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Tacrolimus; Prednisone

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; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Fujun Lin, MD,PhD

CONTACT

+86-13917983703; linfujun@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 6, 2019
• Study Start: November 26, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: June 25, 2019

Record last verified: 2019-03

Locations

CN (1)