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Multitarget therapy versus standard Mycophenolate mofetil for induction treatment of Lupus Nephritis : A randomized controlled trial

Multitarget therapy versus standard Mycophenolate mofetil for induction treatment of Lupus Nephritis : A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200814002
Enrollment
112
Registered
2020-08-14
Start date
2019-11-21
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease remission in lupus nephritis patients between 2 drug regimens Complete remission and time to renal response

Interventions

Mycophenolate mofetil 1.5 g/day titrate to 2 g/day plus standard corticosteroid,Multitarget therapy consists of Tacrolimus&#44
fixed dose Mycophenolate mofetil 1 g/day and standard corticosteroid
Active Comparator Drug,Active Comparator Drug
Standard mycophenolate mofetil,Multitarget therapy

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Biopsy proven lupus nephritis class III/IV/V (new case or relapsed) 2. Pathologic chronicity index (CI) < 4 3. At least 24 hr urine protein 1.5 gm/day in LN class III&#44; V 4. Serum creatinine < 2 mg/dl 5. Patient’s informed consent

Exclusion criteria

Exclusion criteria: 1. Disease progression as rapidly progressive glomerulonephritis 2. History of treatment with Methylprednisolone/ Cyclophosphamide/ Mycophenolate mofetil/ Tacrolimus within 12 weeks before enrollment 3. HBV/ HCV/ HIV co&#45;infection 4. Diabetes Mellitus 5. Pregnancy/ Lactation/ Refused contraception

Design outcomes

Primary

MeasureTime frame
Complete remission 24 weeks Clinical and laboratory assessment

Secondary

MeasureTime frame
Partial remission&#44; overall response rate&#44; time to renal response&#44; safety and adverse effect 24 weeks Clinical and laboratory assessment

Countries

Thailand

Contacts

Public ContactLaddaporn Wongluechai

Renal division&#44; Medicine department&#44; Maharat Nakhon Ratchasima Hospital

eve306@gmail.com0899604229

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026