Comparison Between Tacrolimus (TAC) & Mycophenolate Mofetil (MMF) for

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01580865
Study type	Interventional
Source	Ramathibodi Hospital
Contact
Status	Completed
Phase	N/A
Start date	May 2012
Completion date	March 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02936375` - The Iguratimod Effect on Lupus Nephritis (IGeLU)	Phase 2
Completed	`NCT03597464` - Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin	Phase 3
Recruiting	`NCT01226147` - Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis	Phase 2
Completed	`NCT01206569` - Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis	Phase 4
Active, not recruiting	`NCT00569101` - A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis	Phase 2
Terminated	`NCT00368264` - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )	Phase 2/Phase 3
Completed	`NCT00298506` - Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)	N/A
Completed	`NCT00371319` - Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis	Phase 4
Completed	`NCT00094380` - Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)	Phase 1/Phase 2
Terminated	`NCT04376827` - A Study of Guselkumab in Participants With Active Lupus Nephritis	Phase 2
Completed	`NCT03610516` - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.	Phase 2
Recruiting	`NCT03526042` - Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis	N/A
Withdrawn	`NCT03859570` - Pentoxifylline in Lupus Nephritis	Phase 4
Completed	`NCT03664908` - Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)?	N/A
Completed	`NCT01085097` - A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis	Phase 2
Active, not recruiting	`NCT05704088` - SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients	Phase 4
Not yet recruiting	`NCT06429800` - A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis	Phase 1
Recruiting	`NCT02226341` - ACTHar in the Treatment of Lupus Nephritis	Phase 4
Recruiting	`NCT02453997` - Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis	N/A
Completed	`NCT01470183` - Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms