Alkaline phosphatase to treat ischaemia–reperfusion injury in living‐donor kidney transplantation: APhIRI I feasibility pilot study
Aims Ischemia‐reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evalua...
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Published in | British journal of clinical pharmacology Vol. 89; no. 12; pp. 3629 - 3636 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
01.12.2023
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Subjects | |
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Abstract | Aims
Ischemia‐reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri‐procedural AP administration in living donor kidney transplantation.
Methods
In this double blind, randomized, placebo‐controlled, single‐center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome—graft function at 1 year—was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury.
Results
Eleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant.
Conclusion
This study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced. |
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AbstractList | Aims
Ischemia‐reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri‐procedural AP administration in living donor kidney transplantation.
Methods
In this double blind, randomized, placebo‐controlled, single‐center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome—graft function at 1 year—was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury.
Results
Eleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant.
Conclusion
This study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced. Ischemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri-procedural AP administration in living donor kidney transplantation. In this double blind, randomized, placebo-controlled, single-center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome-graft function at 1 year-was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury. Eleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant. This study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced. AIMSIschemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri-procedural AP administration in living donor kidney transplantation.METHODSIn this double blind, randomized, placebo-controlled, single-center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome-graft function at 1 year-was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury.RESULTSEleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant.CONCLUSIONThis study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced. |
Author | Nurmohamed, Azam S. Vogt, Liffert Heijden, Joost W. Steenvoorden, Thei S. Duin, Robert E. Rood, Janneke A. J. Bemelman, Frederike J. Peters‐Sengers, Hessel |
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Cites_doi | 10.1111/tri.13781 10.1097/TP.0000000000003317 10.3390/jcm9010253 10.1007/s00228‐008‐0591‐6 10.15761/ICM.1000193 10.1111/bph.14752 10.1038/s41591‐019‐0415‐5 10.34067/kid.0002472021 10.1111/bph.13882 10.1093/ndt/gfy019 10.1186/s12014‐021‐09315‐z 10.18637/jss.v082.i13 10.1021/bi700936w 10.5500/wjt.v10.i9.230 10.1681/ASN.2015080879 10.1007/s00134‐019‐05919‐0 10.1111/bph.13261 10.1097/TP.0b013e3182a19348 10.2174/187221309789257388 10.1001/jamanetworkopen.2020.19209 10.3389/fimmu.2014.00064 10.1038/s41581‐021‐00425‐3 10.18637/jss.v067.i01 10.1038/s41581‐020‐0304‐7 10.1038/ki.2010.351 10.3389/fmed.2022.931293 10.1016/j.ijsu.2021.106021 10.1016/j.kint.2018.05.018 10.3389/fimmu.2018.02342 10.1001/jama.2018.14283 |
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Keywords | pilot delayed graft function bRESCAP living-donor kidney transplantation graft survival alkaline phosphatase ischaemia-reperfusion injury |
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Ischemia‐reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has... Ischemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the... AIMSIschemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has... |
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SubjectTerms | Alkaline Phosphatase Biomarkers bRESCAP delayed graft function Feasibility Studies graft survival Humans ischaemia–reperfusion injury Kidney Kidney Transplantation - adverse effects Living Donors living‐donor kidney transplantation pilot Pilot Projects Reperfusion Injury - etiology |
Title | Alkaline phosphatase to treat ischaemia–reperfusion injury in living‐donor kidney transplantation: APhIRI I feasibility pilot study |
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