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Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy | Clinical Trials | Clareo Health

UNKNOWNNA

Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy

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

NCT03864250•Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 18 - 80 years;
•2. Those whose clinical manifestation and renal biopsy pathologic diagnosis are IMN (Stages I-IV) with secondary membranous nephropathy excluded;
•3. 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.
•4. 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;
•5. Patients who have signed the informed consent forms.
+9 more criteria

Exclusion Criteria

•1. Those whose kidney pathological manifestation of interstitial fibrosis is \>30%;
•2. 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;
•3. Those who suffer from untreated active digestive tract ulcer within 3 months before random grouping;
•4. Those who suffer from uncured malignant tumor less than 5 years;
•5. 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;
•6. Those whose ALT, AST or total bilirubin content goes beyond 1.5 times above normal upper limit;
•7. Those who suffer from combined critical complications such as serious infection or other severe organ disease or dysfunction;
•8. Pregnant or lactating women;
•9. Those who are known to be allergic to drugs under trial or relevant products;
•10. Those who participated in other clinical trials within 3 months before inclusion;
+4 more criteria

Locations (1)

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

Shanghai, China

Key Dates

Start Date

November 26, 2018

Primary Completion Date

November 1, 2020

Completion Date

November 1, 2021

Last Updated

June 25, 2019

Enrollment

124

ESTIMATED participants

Conditions

TacrolimusIdiopathic Membranous NephropathyClinical Trial

Interventions

Tacrolimus

DRUG

Prednisone

DRUG

Contacts

Fujun Lin, MD,PhD

CONTACT

+86-13917983703 linfujun@xinhuamed.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy

Inclusion Criteria

Exclusion Criteria

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