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

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

Official Title: Comparison Between Tacrolimus and Mycophenolate Mofetil for Induction of Remission in Lupus Nephritis

Brief 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.

Detailed Summary:

The patients with a pathological diagnosis of active lupus nephritis whom are currently followed up or referred to outpatient department (OPD) of 7 participating medical centers in Thailand. Patients who come to attend will be selected according to the inclusion and exclusion criteria.

Outcome measurements

  • The patients will be follow-up for 1 year and will be evaluated for clinical manifestations and laboratory investigations of lupus nephritis and any adverse effects of therapy on each visit.
  • Blood pressure and laboratory assessments, including complete blood cell count, urinalysis, urine protein creatinine ratio (UPCR), and kidney and liver function, will be performed at each visit for 24 weeks and at the end of study (48 weeks).
  • Serum anti-double-stranded DNA antibodies and serum C3 will be measured every 8 weeks after treatment until 24 weeks and at the end of study (48 weeks).
  • A fasting lipid profile will be also measured every 8 weeks until 24 weeks and at the end of study (48 weeks).
  • Renal and extrarenal disease activity of SLE was measured using the SLEDAI2K. The SLEDAI2K will be evaluated at the time of entry into the study and every 8 weeks after treatment until 24 weeks and at the end of study (48 weeks).
  • SLICC damage index, SF-36, EQ5D, and SLEQOL will be evaluated at the time of entry, at 24 weeks, and at the end of the study.
  • Patients' serum and urine (blood 3ml and urine 50 ml) will be collected at baseline, 2nd week, 4th week, 12th week, and 48th week for further analysis of biomarkers in the future.

Sponsor: Ramathibodi Hospital

Current Primary Outcome: Complete remission [ Time Frame: 1 year ]

urinary protein excretion <0.3 g/24 h with normal urinary sediment, normal serum albumin concentration (serum albumin ≥3.5 g/dL), and stable kidney function (normal serum creatinine range or not >15% more than baseline values)


Original Primary Outcome: Same as current

Current Secondary Outcome: Partial remission [ Time Frame: 1 year ]

urinary protein excretion range of 0.3-2.9 g/24 h and a decrease of at least 50% of baseline level, with serum albumin concentration of at least 3.0 g/dL and stable kidney function.


Original Secondary Outcome: Same as current

Information By: Ramathibodi Hospital

Dates:
Date Received: April 17, 2012
Date Started: May 2012
Date Completion: December 2016
Last Updated: November 2, 2015
Last Verified: November 2015