H-Guard Pilot Safety Evaluation in Haemodialysis Patients : A Within-patient, Pilot Assessment of the Safety and Performance of H-Guard as a Priming Solution for Use in the Set-up of Blood Tubing Sets and Dialysers Prior to Use in Haemodialysis Patients
This prospective, open-label, study will be conducted in accordance with the requirements of EN ISO 14155, the Declaration of Helsinki (revised version of Edinburgh, Scotland 2000), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and the current national regulations and guidelines, approved by both the local ethics committee and regulatory authority.The study will be performed in a stable participant population who are on haemodialysis and who have a blood biomarker profile at screening, suggesting an increased risk of sensitivity to the haemodialysis dialyser and/or blood tubing sets (C3 deposition assay ratio ≤0.3 - measured immunologically using a C3 antibody in H-Guard vs human serum albumin coated ELISA plates). Participants will be recruited based on participation in a prior screening study and will attend a total of six-seven consecutive visits during the clinical trialScreening [up to 30 days prior to the start of the clinical trial]A non-interventional haemodialysis using standard priming solutions [Baseline - mid-week session: Day 0]For WoCBP - a serum hCG test will be repeated between days 1-6 prior to interventionA single haemodialysis using H-Guard to first prime the dialyser and tubing set [mid-week session: Day 7]Followed by a further non-interventional haemodialysis without H-Guard [i.e. using standard priming solutions] [first haemodialysis post intervention]A follow up visit 7 days post intervention to perform antibody analysisFinally a follow up visit 14-21 days post intervention to perform antibody analysis..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 07. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: October 6, 2023, Last downloaded: ClinicalTrials.gov processed this data on March 13, 2024, Last updated: March 13, 2024 |
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| Study ID: |
NCT06070337 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG000068764 |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: October 6, 2023, Last downloaded: ClinicalTrials.gov processed this data on March 13, 2024, Last updated: March 13, 2024 | ||
| 520 | |a This prospective, open-label, study will be conducted in accordance with the requirements of EN ISO 14155, the Declaration of Helsinki (revised version of Edinburgh, Scotland 2000), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and the current national regulations and guidelines, approved by both the local ethics committee and regulatory authority.The study will be performed in a stable participant population who are on haemodialysis and who have a blood biomarker profile at screening, suggesting an increased risk of sensitivity to the haemodialysis dialyser and/or blood tubing sets (C3 deposition assay ratio ≤0.3 - measured immunologically using a C3 antibody in H-Guard vs human serum albumin coated ELISA plates). Participants will be recruited based on participation in a prior screening study and will attend a total of six-seven consecutive visits during the clinical trialScreening [up to 30 days prior to the start of the clinical trial]A non-interventional haemodialysis using standard priming solutions [Baseline - mid-week session: Day 0]For WoCBP - a serum hCG test will be repeated between days 1-6 prior to interventionA single haemodialysis using H-Guard to first prime the dialyser and tubing set [mid-week session: Day 7]Followed by a further non-interventional haemodialysis without H-Guard [i.e. using standard priming solutions] [first haemodialysis post intervention]A follow up visit 7 days post intervention to perform antibody analysisFinally a follow up visit 14-21 days post intervention to perform antibody analysis. | ||
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