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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase III, Randomized, Open, Parallel-controlled, Multi-center Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lu

Brief 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.

Detailed Summary: This is a randomized, open, 1:1 parallel controlled, multi-center, non-inferiority clinical study.
Sponsor: Astellas Pharma China, Inc.

Current Primary Outcome: Remission rate (complete remission + partial remission) [ Time Frame: at 24 weeks ]

complete remission: urine protein < 0.5g/24hr, and serum albumin≥3.5g/dl, and stable renal function (Scr increase ≤ 15% baseline value) partial remission: urine protein 0.5-3.5g/24hr (≥ 0.5 g/24hr and < 3.5 g/24hr), and urine protein decreased by >50% comparing with the baseline, and serum albumin ≥ 3.0g/dl, and stable renal function (Scr increase ≤ 15% baseline value)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 24-hour urine protein [ Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24 ]
  • Change of 24-hour urine protein from baseline [ Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24 ]
  • Serum albumin [ Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24 ]
  • Change of Serum albumin from baseline [ Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24 ]
  • Serum creatinine [ Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24 ]
  • Change of Serum creatinine from baseline [ Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24 ]
  • eGFR comparing with baseline [ Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24 ]
    eGFR: Estimated Glomerular Filtration Rate
  • Percentage of patients converted to other immunosuppressive therapy [ Time Frame: during 24 weeks ]
  • Percentage of patients with serum creatinine rising to two times of the baseline [ Time Frame: during 24 weeks ]
  • Percentage of patients with dsDNA and ANA converting from positive to negative [ Time Frame: during 24 weeks ]
    ANA: Antinuclear Antibody
  • SLE-DAI [ Time Frame: at Week 4, 12 and 24 ]
    SLE-DAI: Systemic Lupus Erythematosus - Disease Activity Index
  • Immune parameters assessed by ESR, C3, C4 and dsDNA [ Time Frame: at Week 4, 12 and 24 ]
    ESR: Erythrocyte Sedimentation Rate, C3, C4: Complement C3, C4, dsDNA: Anti-Double-Stranded DNA Antibodies
  • Change of SLE-DAI from baseline [ Time Frame: at Week 4, 12 and 24 ]
  • Change of immune parameters from baseline [ Time Frame: at Week 4, 12 and 24 ]
  • Renal biopsy AI (Active Index) [ Time Frame: at Week 24 ]
  • CI (Chronic Index) [ Time Frame: at Week 24 ]
  • Change of Renal biopsy AI (Active Index) from baseline [ Time Frame: at Week 24 ]
  • Change of CI (Chronic Index) from baseline [ Time Frame: at Week 24 ]


Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: May 22, 2015
Date Started: March 10, 2015
Date Completion: June 30, 2018
Last Updated: April 27, 2017
Last Verified: April 2017