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Comparison Between Tacrolimus (TAC) and Mycophenolate Mofetil (MMF) for Induction of Remission in Lupus Nephritis

NCT01580865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2018-09-12

No results posted yet for this study

Summary

Prospective, multi-center, randomized, controlled, trial to compare tacrolimus with mycophenolate mofetil (MMF) for induces complete remission in lupus nephritis patients. The study duration is one year.

Research hypothesis

* The proportion of patients who have achieved complete remission between regimen of tacrolimus plus prednisolone is greater than MMF plus prednisolone as an induction therapy in lupus nephritis.

Conditions

Interventions

DRUG

Tacrolimus vs. Mycophenolate mofetil for Induction Therapy in Lupus Nephritis

Patients were randomly assigned to receive regimen I or II: TAC plus prednisolone (TAC group) or MMF plus prednisolone (MMF group). TAC was started at a dosage of 0.1 mg/kg/day divided into 2 daily doses at 12-hour intervals, and the dosage was titrated to achieve trough blood concentrations of 6-10 ng/mL in the first and second month and then 4-8 ng/mL., thereafter. MMF was initiated at a dose of 500 mg twice daily (for patients \> 50 Kg and Estimated Glomerular Filtration rate (eGFR) \> 60 ml/min) for 2 weeks, and advanced to 750 mg twice daily in LN patients weighing less than 50 kg or 1,000 mg twice daily in LN patients weighing 50 kg or more. Patients received concomitant prednisone at a dose of 0.5-0.7 mg/kg/d (maximum 60 mg/day), with tapering by 5-10 mg/day every 2 weeks until a dose of 5 mg/d has been achieved, and this dosage was maintained until the end of 24 weeks.

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    collaborator OTHER

  • Maharaj Nakorn Chiang Mai Hospital

    collaborator OTHER

  • Department of Medical Services Ministry of Public Health of Thailand

    collaborator OTHER_GOV

  • Srinagarind Hospital, Khon Kaen University

    collaborator OTHER

  • Siriraj Hospital

    collaborator OTHER

  • Songklanagarind Hospital

    collaborator UNKNOWN

  • Ramathibodi Hospital

    lead OTHER

Principal Investigators

  • Vasant Sumethkul, Prof. · Ramathibodi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Thailand

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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 NCT01580865 on ClinicalTrials.gov