Summary
Chronic Kidney Disease (CKD) is one of the major causes of death in high income countries and its prevalence is growing rapidly. New therapies for the treatment of CKD have shown clear efficacy at a population level. Yet, individual patients respond differently with many patients showing suboptimal efficacy. This indicates that a ‘one size fits all’ approach is no longer sustainable.
Currently there are no validated pharmacodynamic biomarkers in CKD that aid in guiding optimal therapy for individual patients. Furthermore, there remains a large gap between biomarker research and actual implementation of biomarker based care in daily clinical practice.
Thus, there is an urgent need to validate and translate biomarkers as tools for daily clinical practice. PRIME-CKD has a unique advantage to address this challenge as it builds on recently discovered pharmacodynamic biomarkers for CKD treatment, and has access to a vast amount of clinical data, bio-samples. PRIME CKD will:
1) Provide a breakthrough in the pharmacotherapy of CKD with the validation and implementation of pharmacodynamic biomarkers which will advance personalized medicine.
2) Scientifically validate innovative clinical trial elements, pipelines and qualification procedures that can be used by researchers, diagnostics industries and regulatory authorities.
3) Establish a Stakeholder Network to truly engage patients, clinicians and other stakeholders in implementation of personalized medicines
4) Develop a roadmap for biomarker use in daily clinical practice for the optimal treatment of CKD.
These results will enable clinicians to match patients with CKD with the most effective available drug within the shortest possible timeframe leading to less disease burden and progression of disease, enhanced quality of life and increased cost-efficiency. PRIME-CKD results will thus unlock the potential of biomarkers in healthcare and close the gap between biomarker research and clinical use in daily practice.
Currently there are no validated pharmacodynamic biomarkers in CKD that aid in guiding optimal therapy for individual patients. Furthermore, there remains a large gap between biomarker research and actual implementation of biomarker based care in daily clinical practice.
Thus, there is an urgent need to validate and translate biomarkers as tools for daily clinical practice. PRIME-CKD has a unique advantage to address this challenge as it builds on recently discovered pharmacodynamic biomarkers for CKD treatment, and has access to a vast amount of clinical data, bio-samples. PRIME CKD will:
1) Provide a breakthrough in the pharmacotherapy of CKD with the validation and implementation of pharmacodynamic biomarkers which will advance personalized medicine.
2) Scientifically validate innovative clinical trial elements, pipelines and qualification procedures that can be used by researchers, diagnostics industries and regulatory authorities.
3) Establish a Stakeholder Network to truly engage patients, clinicians and other stakeholders in implementation of personalized medicines
4) Develop a roadmap for biomarker use in daily clinical practice for the optimal treatment of CKD.
These results will enable clinicians to match patients with CKD with the most effective available drug within the shortest possible timeframe leading to less disease burden and progression of disease, enhanced quality of life and increased cost-efficiency. PRIME-CKD results will thus unlock the potential of biomarkers in healthcare and close the gap between biomarker research and clinical use in daily practice.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101095146 |
| Start date: | 01-01-2023 |
| End date: | 31-12-2027 |
| Total budget - Public funding: | 9 242 241,01 Euro - 9 242 240,00 Euro |
Cordis data
Original description
Chronic Kidney Disease (CKD) is one of the major causes of death in high income countries and its prevalence is growing rapidly. New therapies for the treatment of CKD have shown clear efficacy at a population level. Yet, individual patients respond differently with many patients showing suboptimal efficacy. This indicates that a ‘one size fits all’ approach is no longer sustainable.Currently there are no validated pharmacodynamic biomarkers in CKD that aid in guiding optimal therapy for individual patients. Furthermore, there remains a large gap between biomarker research and actual implementation of biomarker based care in daily clinical practice.
Thus, there is an urgent need to validate and translate biomarkers as tools for daily clinical practice. PRIME-CKD has a unique advantage to address this challenge as it builds on recently discovered pharmacodynamic biomarkers for CKD treatment, and has access to a vast amount of clinical data, bio-samples. PRIME CKD will:
1) Provide a breakthrough in the pharmacotherapy of CKD with the validation and implementation of pharmacodynamic biomarkers which will advance personalized medicine.
2) Scientifically validate innovative clinical trial elements, pipelines and qualification procedures that can be used by researchers, diagnostics industries and regulatory authorities.
3) Establish a Stakeholder Network to truly engage patients, clinicians and other stakeholders in implementation of personalized medicines
4) Develop a roadmap for biomarker use in daily clinical practice for the optimal treatment of CKD.
These results will enable clinicians to match patients with CKD with the most effective available drug within the shortest possible timeframe leading to less disease burden and progression of disease, enhanced quality of life and increased cost-efficiency. PRIME-CKD results will thus unlock the potential of biomarkers in healthcare and close the gap between biomarker research and clinical use in daily practice.
Status
SIGNEDCall topic
HORIZON-HLTH-2022-TOOL-11-01Update Date
09-02-2023
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Organisations
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| ACADEMISCH ZIEKENHUIS GRONINGEN (Coördinator)
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| AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN
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| ALMA MATER STUDIORUM-UNIVERSITA DI BOLOGNA
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| FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
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| HESSELS EN GROB BV
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| IRCCS AZIENDA OSPEDALIERO- UNIVERSITARIA DI BOLOGNA
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| LUNDS UNIVERSITET
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| NIERSTICHTING NEDERLAND
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| REGION HOVEDSTADEN
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| RENALYTIX AI LIMITED
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| UMCG RESEARCH BV
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| UNIVERSITA DEGLI STUDI DELLA CAMPANIA LUIGI VANVITELLI
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| UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
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| UNIVERSITATSKLINIKUM ERLANGEN
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| UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST