Transplant Trial Watch

Efficacy and Safety of Iguratimod Supplement to the Standard Immunosuppressive Regimen in Highly Mismatched Renal Transplant Recipients: A Pilot Study.

Tao, J., et al.

Frontiers in Immunology 2021; 12: 738392.

This study aimed to assess the effect and safety of Iguratimod (IGU) combined with standard immunosuppressive regimen in highly HLA-mismatched kidney transplant patients.

Patients were randomised to either the IGU or non-IGU group.

60 highly HLA-mismatched renal transplant recipients.

The primary outcomes were biopsy-proven acute rejection and functional allograft survival. The secondary outcomes were the safety profile, donor-specific antibody (DSA) and other indicators.

52 weeks

CET Conclusions
This small pilot RCT investigated whether the addition of the disease-modifying anti-rheumatoid drug (DMARD) Iguratimod (IGU) can improve outcomes in poorly-mismatched renal transplant recipients. The study itself was unblinded, but nephrologists scoring protocol biopsies were blinded to treatment allocation. Both modified intent-to-treat and per-protocol analyses are reported. Patients receiving IGU had numerically lower incidence of biopsy-proven acute rejection, although not achieving statistical significance due to the small sample size. The results presented do show some promise for the use of IGU following renal transplantation, but larger studies will be required to confirm any benefit. It should be noted that the baseline rate for biopsy-proven acute rejection was relatively high for a Tac/MMF/Pred based regimen (29.6%). Another potential limitation is that patients were only eligible at least 2 weeks post-transplant – anti-inflammatory drugs of this nature may be most effective if given from the day of transplant.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration - NCT02839941

Funding source
Non-industry funded