Trial reportEuropean journal of clinical pharmacology2009
Clinical pharmacology of exogenously administered alkaline phosphatase.
Trial report in European journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00430859 (A Pilot, Double-blind, Randomised, Placebo-controlled, Exploratory Study to Investigate the Safety and Effect of Bovine Intestinal Alkaline Phosphatase in Patients With Sepsis), which is not on this map. Cited by 23 papers.
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 Pilot, Double-blind, Randomised, Placebo-controlled, Exploratory Study to Investigate the Safety and Effect of Bovine Intestinal Alkaline Phosphatase in Patients With Sepsis
Who cites it
23 citing papers in PubMed, 37 citations in OpenAlex.
- Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL).Intensive care medicine · 2024Trial
- Supplemented Alkaline Phosphatase Supports the Immune Response in Patients Undergoing Cardiac Surgery: Clinical and Computational Evidence.Frontiers in immunology · 2018Trial
- Pharmacokinetic Modeling and Dose Selection in a Randomized, Double-Blind, Placebo-Controlled Trial of a Human Recombinant Alkaline Phosphatase in Healthy Volunteers.Clinical pharmacokinetics · 2016Trial
- Alkaline phosphatase for treatment of sepsis-induced acute kidney injury: a prospective randomized double-blind placebo-controlled trial.Critical care (London, England) · 2012Trial
- 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
- ABCB5⁺ mesenchymal stem cells enable high-ratio cellular augmentation of bone grafts without loss of osteogenic function.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2026Article
- Evaluating Alkaline Phosphatase-Instructed Self-Assembly of d‑Peptide Diesters for Selectively Inhibiting Immunosuppressive Cancer Cells.ACS omega · 2026Article
- Predictors of Hypocalcemia Post Parathyroidectomy for Primary Hyperparathyroidism; a Single Center Study.Endocrinology, diabetes & metabolism · 2025Article
- Evaluation of the immunological functions of placental alkaline phosphataseFrontiers in immunology · 2025Article
- Development and application of a simple pharmacokinetic model that quantitatively describes the distribution and elimination of the commonly measured proteins.ADMET & DMPK · 2023Article
- Intestinal Alkaline Phosphatase: A Review of This Enzyme Role in the Intestinal Barrier Function.Microorganisms · 2022Review
- Alkaline Phosphatase Pathophysiology with Emphasis on the Seldom-Discussed Role of Defective Elimination in Unexplained Elevations of Serum ALP - A Case Report and Literature Review.Clinical and experimental gastroenterology · 2022Article
- Tissue-Nonspecific Alkaline Phosphatase in Central Nervous System Health and Disease: A Focus on Brain Microvascular Endothelial Cells.International journal of molecular sciences · 2021Review
- Tissue alkaline phosphatase activity and expression in an experimental infant swine model of cardiopulmonary bypass with deep hypothermic circulatory arrest.Journal of inflammation (London, England) · 2020Article
- Alkaline phosphatase: a potential biomarker for stroke and implications for treatment.Metabolic brain disease · 2019Review
- Innovative Drugs to Target Renal Inflammation in Sepsis: Alkaline Phosphatase.Frontiers in pharmacology · 2019Review
- Change in alkaline phosphatase activity associated with intensive care unit and hospital length of stay in patients with septic acute kidney injury on continuous renal replacement therapy.BMC nephrology · 2018Observational
- Acute kidney injury in the ICU: from injury to recovery: reports from the 5th Paris International Conference.Annals of intensive care · 2017Review
- Human alkaline phosphatase dephosphorylates microbial products and is elevated in preterm neonates with a history of late-onset sepsis.PloS one · 2017Article
- Article
Corrections and comments
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Authors and funding
12 authors at 10 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the clinical pharmacology of exogenous alkaline phosphatase (AP).
methodsRandomized, double-blind, placebo-controlled sequential protocols of (1) ascending doses and infusion duration (volunteers) and (2) fixed dose and duration (patients) were conducted at clinical pharmacology and intensive care units. A total of 103 subjects (67 male volunteers and 36 patients with severe sepsis) were administered exogenous, 10-min IV infusions (three ascending doses) or 24-72 h continuous (132.5-200 U kg(-1) 24 h(-1)) IV infusion with/without preceding loading dose and experimental endotoxemia for evaluations of pharmacokinetics, pharmacodynamics, safety parameters, antigenicity, inflammatory markers, and outcomes.
resultsLinearity and dose-proportionality were shown during 10-min infusions. The relatively short elimination half-life necessitated a loading dose to achieve stable enzyme levels. Pharmacokinetic parameters in volunteers and patients were similar. Innate immunity response was not significantly influenced by AP, while renal function significantly improved in sepsis patients.
conclusionsThe pharmacokinetics of exogenous AP is linear, dose-proportional, exhibit a short half-life, and are not influenced by renal impairment or dialysis.
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What OpenQuestion holds
Registered trials
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.