Trial reportIntensive care medicine2024
Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL).
Trial report in Intensive care medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04411472 (A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI), which is not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI
Who cites it
42 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.
- Sex and gender considerations in randomized controlled trials in critical care nephrology: a meta-epidemiologic study.BMC medicine · 2025Pooled it
- A randomized Phase 1b trial evaluating the pharmacodynamics of ilofotase alfa in adults with hypophosphatasia.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026Trial
- Phenotype-specific therapeutic efficacy of ilofotase alfa in patients with sepsis-associated acute kidney injury.Critical care (London, England) · 2024Trial
- A multicenter randomized, double-blinded placebo-controlled phase 2 trial to evaluate safety and efficacy of ilofotase alfa in patients at risk for kidney injury following open heart surgery.Intensive care medicine · 2026Article
- Plasma proteomics defines two reproducible subphenotypes of sepsis-associated acute kidney injury with distinct outcomes.Nature communications · 2026Article
- Effects and Mechanism of 2'-AMP on Renal Vascular Resistance: Role of P2X1 Receptors.Journal of the American Society of Nephrology : JASN · 2026Article
- Engineered M2 macrophage-derived vesicles deliver DNase I for cfDNA clearance and multi-organ protection in sepsis.International journal of pharmaceutics: X · 2026Article
- Engineering a T7 bacteriophage to attenuate LPS-driven inflammatory responses during bacteriolysis.Applied and environmental microbiology · 2026Article
- Mesenchymal stem cell-derived small extracellular vesicles suppress pyroptosis by delivering miR-125a-5p to improve acute kidney injury in sepsis.Cell death discovery · 2026Article
- REAL208, a Liposome-based Formulation of Phosphodiesterase Inhibitor, Protects Acute Kidney Deficiency in Mice.Pharmaceutical research · 2026Article
- Long-chain polyphosphates induce glomerular microthrombi and exacerbate LPS-induced acute kidney injury in mouse.Disease models & mechanisms · 2026Article
- Current Status and Future Prospects of Research on Sepsis-Related Acute Kidney Injury.International journal of molecular sciences · 2026Review
- Construction and Validation of a Nomogram Based on Preoperative Inflammatory Indicators for Predicting Acute Kidney Injury After Pancreaticoduodenectomy.Journal of inflammation research · 2026Article
- Complement in acute kidney injury: a convergent pathogenic pathway in multifactorial renal damage.Frontiers in immunology · 2026Review
- Clinical outcomes of persistent sepsis-associated acute kidney injury in septic shock: a post-hoc analysis of a multicenter prospective cohort study.Annals of intensive care · 2026Article
- Review
- Enhancing prognostic accuracy in sepsis-induced cardiomyopathy: a machine learning approach.European journal of medical research · 2025Article
- The therapeutic horizon of acute kidney injury in critical care: exploring pathology, promises, pitfalls, and progress.Current opinion in critical care · 2025Review
- Role of RIPK1/RIPK3/MLKL signalling pathway in sepsis-associated acute kidney injury.Experimental physiology · 2025Review
- Acute kidney injury: pathogenesis and therapeutic interventions.Molecular biomedicine · 2025Review
Corrections and comments
- AssociatedPublication
- Commented on by
- Erratum issued
Authors and funding
30 authors at 20 institutions in 15 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIlofotase alfa is a human recombinant alkaline phosphatase with reno-protective effects that showed improved survival and reduced Major Adverse Kidney Events by 90 days (MAKE90) in sepsis-associated acute kidney injury (SA-AKI) patients. REVIVAL, was a phase-3 trial conducted to confirm its efficacy and safety.
methodsIn this international double-blinded randomized-controlled trial, SA-AKI patients were enrolled < 72 h on vasopressor and < 24 h of AKI. The primary endpoint was 28-day all-cause mortality. The main secondary endpoint was MAKE90, other secondary endpoints were (i) days alive and free of organ support through day 28, (ii) days alive and out of the intensive care unit (ICU) through day 28, and (iii) time to death through day 90. Prior to unblinding, the statistical analysis plan was amended, including an updated MAKE90 definition.
resultsSix hundred fifty patients were treated and analyzed for safety; and 649 for efficacy data (ilofotase alfa n = 330; placebo n = 319). The observed mortality rates in the ilofotase alfa and placebo groups were 27.9% and 27.9% at 28 days, and 33.9% and 34.8% at 90 days. The trial was stopped for futility on the primary endpoint. The observed proportion of patients with MAKE90A and MAKE90B were 56.7% and 37.4% in the ilofotase alfa group vs. 64.6% and 42.8% in the placebo group. Median [interquartile range (IQR)] days alive and free of organ support were 17 [0-24] and 14 [0-24], number of days alive and discharged from the ICU through day 28 were 15 [0-22] and 10 [0-22] in the ilofotase alfa and placebo groups, respectively. Adverse events were reported in 67.9% and 75% patients in the ilofotase and placebo group.
conclusionAmong critically ill patients with SA-AKI, ilofotase alfa did not improve day 28 survival. There may, however, be reduced MAKE90 events. No safety concerns were identified.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.