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Fulltext Recommendations by the Asian Pacific society of nephrology (APSN) on the appropriate use of HIF-PH inhibitors

Yap DYH, McMahon LP, Hao CM, Hu N, Okada H, Suzuki Y, et al.

Nephrology (Carlton), 2021 Feb;26(2):105-118.
PMID: 33222343 DOI: 10.1111/nep.13835

Renal anaemia is a common and important complication in patients with chronic kidney disease (CKD). The current standard-of-care treatment for renal anaemia in CKD patients involves ensuring adequate iron stores and administration of erythropoietin stimulating agents (ESA). Hypoxia inducible factor (HIF) is a key transcription factor primarily involved in the cellular regulation and efficiency of oxygen delivery. Manipulation of the HIF pathway by the use of HIF-prolyl hydroxylase inhibitors (HIF-PHI) has emerged as a novel approach for renal anaemia management. Despite it being approved for clinical use in various Asia-Pacific countries, its novelty mandates the need for nephrologists and clinicians generally in the region to well understand potential benefits and harms when prescribing this class of drug. The Asian Pacific society of nephrology HIF-PHI Recommendation Committee, formed by a panel of 11 nephrologists from the Asia-Pacific region who have clinical experience or have been investigators in HIF-PHI studies, reviewed and deliberated on the clinical and preclinical data concerning HIF-PHI. This recommendation summarizes the consensus views of the committee regarding the use of HIF-PHI, taking into account both available data and expert opinion in areas where evidence remains scarce.
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, Navarra SV, Ni Z, Avihingsanon Y, Lim SK, Zhi H, et al.

Kidney Int, 2026 Sep 28.
PMID: 42805336 DOI: 10.1016/j.kint.2026.08.026

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.

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