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Recombinant human alkaline phosphataseWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug87 AT-001 Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D018805 Sepsis NIH 0.45
D058186 Acute Kidney Injury NIH 0.24

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0100806 Sepsis HPO 0.45
HP:0001919 Acute kidney injury HPO 0.24

There is one clinical trial.

Clinical Trials

1 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

Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis. 1400 patients will be included in the study that is conducted in approx. 100 ICU's in Europe and North America There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.

NCT04411472 Acute Kidney Injury Due to Sepsis Biological: Recombinant human alkaline phosphatase Other: Placebo
MeSH:Sepsis Acute Kidney Injury
HPO:Acute kidney injury Sepsis

Primary Outcomes

Description: To demonstrate an effect of recAP on 28 day all cause mortality

Measure: 28-day all-cause mortality

Time: 28 days

Secondary Outcomes

Description: MAKE 90: dead or on RRT or ≥25% decline in estimated glomerular filtration rate (eGFR) on Day 90 relative to the known or assumed pre-AKI reference level.

Measure: To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).

Time: 90 Days

Description: Days alive and free of organ support through Day 28, i.e., days alive with no MV, RRT, vasopressors or inotropes (with death within 28 days counting as zero days).

Measure: To investigate the effect of recAP on use of organ support, i.e., mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors or inotropes.

Time: 28 days

Description: Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

Measure: To investigate the effect of recAP on length of stay (LOS) in ICU.

Time: 28 days

Description: Time to death through Day 90.

Measure: To investigate the effect of recAP on 90-day allcause mortality

Time: 90 days

Related HPO nodes (Using clinical trials)

HP:0001919: Acute kidney injury
Genes 29
STOX1 TCN2 DGKE SAA1 CFH LPIN1 CD46 C3 CD46 FLT1 CACNA1S CFB RYR1 CFH APRT HPRT1 HNF1B CCND1 CORIN CFHR1 HELLPAR CFI SLC26A1 THBD PYGM CFHR3 HNF4A CFI SLC22A12
Protein Mutations 0
SNP 0
HP:0100806: Sepsis
Genes 78
PLEC CYBB CYBC1 VPS33A IL7R CYBA LIG4 LMOD1 IL2RG ALOX12B IL7R G6PC3 RET BLNK WIPF1 SULT2B1 IL2RG NIPAL4 CD79A ECE1 FOXP3 EDNRB NCF2 APC CTCF SEMA3C SERAC1 IKZF1 MNX1 CXCR4 IGHM MYH11 ABCA12 NFKB2 RAG1 TCF3 TFRC ELANE SAMD9 PIK3R1 MYLK RAG2 CYP4F22 NCF4 WAS COG4 GALT ADA AK2 RMRP ACTG2 CTNNB1 NRTN NCF1 FERMT3 HYOU1 AK2 BTK ATP7A CD40LG SEMA3D ALOXE3 TGM1 MMUT ITGB4 LRRC8A PGM3 DCLRE1C HLA-B EDN3 CTLA4 LIPN GDNF CD79B CHD7 IGLL1 RAG1 SDR9C7
Protein Mutations 2
G20210A N682S
SNP 8
rs150018775 rs2234237 rs2234237r25r rs2234246 rs3210140 rs4883263 rs4883264 rs61729512