Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

NCT02630628 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-09-25

No results posted yet for this study

Summary

Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with tacrolimus and corticosteroids combined with mycophenolate mofetil.

Conditions

Interventions

DRUG

Tacrolimus

Dosage: start at 2mg twice a day, then titrated according to therapeutic drug level monitoring using 12-hour post-dose blood sampling

DRUG

Mycophenolate mofetil

Dosage: start at 1g twice a day, then taper as per protocol

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Tak-Mao Daniel Chan · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-05
Primary Completion
2024-12-27
Completion
2024-12-27

Countries

  • Hong Kong

Study Locations

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Entities

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 NCT02630628 on ClinicalTrials.gov