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Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis

NCT04768465 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2021-02-24

No results posted yet for this study

Summary

This study is designed to evaluate the effectiveness and safety of tacrolimus combined with low-dose prednisone in the management of myasthenia gravis patients, compared to tacrolimus as initial immune monotherapy.

Conditions

Interventions

DRUG

Pyridostigmine, Prednisone, Tacrolimus

Dose of tacrolimus should be initiated based on CYP3A5\*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Prednisone is administrated with an initial dose of 0.25mg/kg/d and started to tamper with the achievement of MMS or the presence of any intolerable side effects. The rate of tampering is considered by the physician, usually no more than 5mg/month. If the participants failed to maintain MMS, dose of prednisone should be increased 5mg/week to 0.25mg/kg/d and maintained until MMS reached again. After MMS sustained for 1 month, prednisone dose would be tapered again with 2.5mg/month. Calcium and potassium supplements and gastric mucosa protectors could be addressed to avoid any adverse effects of prednisone. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.

DRUG

Pyridostigmine, Tacrolimus

Dose of tacrolimus should be initiated based on CYP3A5\*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.

Sponsors & Collaborators

  • Da, Yuwei, M.D.

    lead INDIV

Principal Investigators

  • Yuwei Da, M.D. · Xuanwu Hospital, Beijing

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768465 on ClinicalTrials.gov