A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis

NCT02457221 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2024-11-01

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.

Conditions

Interventions

DRUG

Tacrolimus capsules

oral

DRUG

Cyclophosphamide injections

intravenous injection

DRUG

Prednisone

oral

Sponsors & Collaborators

  • Astellas Pharma China, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma China, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-10
Primary Completion
2018-09-10
Completion
2018-09-10

Countries

  • China

Study Locations

More Related Trials

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 NCT02457221 on ClinicalTrials.gov