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1 Disease |  |
1 Trial |
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1 Trial |  |
20 News |  |
- | recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Journal: Phenotype-specific therapeutic efficacy of ilofotase alfa in patients with sepsis-associated acute kidney injury. (Pubmed Central) - Feb 24, 2024
We identified a clinical phenotype comprising severely ill patients with underlying kidney disease who benefitted most from ilofotase alfa treatment. This yields insight into the therapeutic potential of this novel treatment in more homogeneous patient groups and could guide patient selection in future trials, showing promise for personalized medicine in SA-AKI and other complex conditions.
- ||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
P3 data, Journal: Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL). (Pubmed Central) - Jan 29, 2024
There may, however, be reduced MAKE90 events. No safety concerns were identified.
- || recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Biomarker, Trial completion: Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia (clinicaltrials.gov) - Dec 1, 2023
P1/2, N=12, Completed, Sponsor: AM-Pharma
No safety concerns were identified. Recruiting --> Completed
- || recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Biomarker, New P1/2 trial: Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia (clinicaltrials.gov) - Jun 6, 2023
P1/2, N=12, Recruiting, Sponsor: AM-Pharma
Recruiting --> Completed .
- ||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
P3 data, Journal: Study protocol of a randomised, double-blind, placebo-controlled, two-arm parallel-group, multi-centre phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with sepsis-associated acute kidney injury. (Pubmed Central) - Apr 4, 2023
P3
US IND Number 117?605 Pre-results. gov number: NCT04411472.
- | recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI (clinicaltrials.gov) - Sep 10, 2022
P3, N=661, Terminated, Sponsor: AM-Pharma
gov number: NCT04411472. N=1600 --> 661 | Trial completion date: Feb 2024 --> Aug 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2023 --> Aug 2022; The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met and that there was no safety concern.
- ||||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Enrollment closed: (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI (clinicaltrials.gov) - Aug 19, 2022
P3, N=1600, Active, not recruiting, Sponsor: AM-Pharma
N=1600 --> 661 | Trial completion date: Feb 2024 --> Aug 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2023 --> Aug 2022; The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met and that there was no safety concern. Recruiting --> Active, not recruiting
- | recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Preclinical, Journal: Human Recombinant Alkaline Phosphatase (Ilofotase Alfa) Protects Against Kidney Ischemia-Reperfusion Injury in Mice and Rats Through Adenosine Receptors. (Pubmed Central) - Aug 17, 2022
In an AKI-on-CKD ischemic rat model, ilofotase alfa given after the third instance of IRI reduced injury. These results suggest that ilofotase alfa promotes production of adenosine from liberated ATP in injured kidney tissue, thereby amplifying endogenous mechanisms that can reverse tissue injury, in part through AR-and non-AR-dependent signaling pathways.
- || recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Trial completion: Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects (clinicaltrials.gov) - Mar 14, 2022
P1, N=34, Completed, Sponsor: AM-Pharma
These results suggest that ilofotase alfa promotes production of adenosine from liberated ATP in injured kidney tissue, thereby amplifying endogenous mechanisms that can reverse tissue injury, in part through AR-and non-AR-dependent signaling pathways. Recruiting --> Completed
- || recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
New P1 trial: Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects (clinicaltrials.gov) - Jun 11, 2021
P1, N=32, Recruiting, Sponsor: AM-Pharma
- |||||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Enrollment open: (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI (clinicaltrials.gov) - Oct 21, 2020
P3, N=1600, Recruiting, Sponsor: AM-Pharma
Recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
New P3 trial: (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI (clinicaltrials.gov) - Jun 1, 2020
P3, N=1400, Not yet recruiting, Sponsor: AM-Pharma
- |||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Trial completion: STOP-AKI: A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (clinicaltrials.gov) - Dec 6, 2017
P2a/2b, N=301, Completed, Sponsor: AM-Pharma
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Enrollment closed: STOP-AKI: A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (clinicaltrials.gov) - Jun 29, 2017
P2a/2b, N=301, Active, not recruiting, Sponsor: AM-Pharma
Active, not recruiting --> Completed Completed --> Active, not recruiting
- |||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Trial completion, Phase classification, Trial primary completion date: STOP-AKI: A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (clinicaltrials.gov) - Jun 22, 2017
P2a/2b, N=301, Completed, Sponsor: AM-Pharma
Completed --> Active, not recruiting Recruiting --> Completed | Phase classification: P2 --> P2a/2b | Trial primary completion date: Dec 2016 --> May 2017
- || recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Trial primary completion date: STOP-AKI: A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (clinicaltrials.gov) - Jan 28, 2016
P2, N=290, Recruiting, Sponsor: AM-Pharma
Recruiting --> Completed | Phase classification: P2 --> P2a/2b | Trial primary completion date: Dec 2016 --> May 2017 Trial primary completion date: Dec 2015 --> Dec 2016
- |||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
Enrollment open: STOP-AKI: A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (clinicaltrials.gov) - Jan 20, 2015
P2, N=290, Recruiting, Sponsor: AM-Pharma
Trial primary completion date: Dec 2015 --> Dec 2016 Not yet recruiting --> Recruiting
- ||||| recombinant human alkaline phosphatase intravenous (recAP) / AM Pharma
New P2 trial: STOP-AKI: A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (clinicaltrials.gov) - Jul 8, 2014
P2, N=290, Not yet recruiting, Sponsor: AM-Pharma