Prospective 96-week study to evaluate efficacy and safety of tacrolimus and glucocorticoid against mycophenolate and glucocorticoid as continuous induction-maintenance treatment for Class III/IV without or with Class V lupus nephritis

Yap DYH 1 , Navarra SV 2 , Ni Z 3 , Avihingsanon Y 4 , Lim SK 5 , Zhi H 6 Show all authors , Takeuchi T 7 , Liew STA 8 , Chan SCW 1 , Chan C 1 , Wu JS 1 , Jiang N 3 , Liu WJ 9 , Chen W 10 , Li C 11 , Zhang C 12 , Collante MTM 2 , Zamora L 2 , Kikuchi J 7 , Yung S 1 , Chan TM 13 , Asian Lupus Nephritis Network Investigators

Affiliations 

  • 1 Department of Medicine, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong
  • 2 Section of Rheumatology, Department of Medicine, University of Santo Tomas Hospital, Manila, Philippines
  • 3 Department of Nephrology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
  • 4 Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
  • 5 Renal Division, Department of Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 6 Biostatistics and Clinical Research Methodology Unit, School of Public Health, The University of Hong Kong, Hong Kong
  • 7 Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
  • 8 Department of Renal Medicine, Tan Tock Seng Hospital, Singapore
  • 9 Department of Medicine and Nephrology, Hospital Sultanah Aminah Johor Bahru, Malaysia
  • 10 Department of Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
  • 11 Department of Nephrology, Peking Union Medical College Hospital, Beijing, China
  • 12 Department of Medicine, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China
  • 13 Department of Medicine, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong. Electronic address: dtmchan@hku.hk
Kidney Int, 2026 Sep 28.
PMID: 42805336 DOI: 10.1016/j.kint.2026.08.026

Abstract

INTRODUCTION: We conducted a prospective Asian multicenter randomized controlled trial to evaluate the efficacy and safety of tacrolimus (TAC) and glucocorticoid (GC), against standard-of-care mycophenolate (MMF) and GC, as continuous induction-maintenance therapy for active lupus nephritis (LN) (ClinicalTrials.gov ID: NCT02630628).

METHODS: One Hundred thirty biopsy-proven patients with Class III/IV without or with Class V LN were randomized to receive GC (intravenous methylprednisolone for three days then oral prednisolone) with either TAC (target trough level 6 - 8ng/mL) or MMF (1g twice a day) for 96 weeks. Primary endpoint was Sustained Renal Response (SRR) at week 96, defined as proteinuria reduction over 50% and estimated glomerular filtration rate no less than 60mL/min per 1.73m2, and no disease flare or rescue therapies. Secondary endpoints included rates of Complete Renal Remission (CRR) and Partial Renal Remission (PRR) at week 96, SRR at week 48, and adverse events (AE).

RESULTS: TAC and MMF groups (65 patients each) showed no significant difference in the rates of SRR (58.5% vs 69.2% respectively) and CRR (55.4% vs 63.1% respectively) at week 96. SRR rates for TAC and MMF groups were 63.1% vs 66.2% at week 48, respectively. Overall, AE rates did not differ between TAC and MMF groups (80.0% in both). Acute kidney injury and tremors were more frequent in TAC group, while leucopoenia was more frequent in MMF group. Three deaths occurred, all in the MMF group. Treatment-related serious adverse events (SAE) and infection resulting in SAE were significantly more frequent in the MMF group.

CONCLUSIONS: Dual immunosuppressive regimen with TAC and GC showed no difference in efficacy but different safety profile compared with MMF and GC over 96 weeks, when used as continuous induction-maintenance treatment for LN.

TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02630628.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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