Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
130 participants
OBSERVATIONAL
2020-03-01
2025-06-01
Brief Summary
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The aim of the study is to examine (a) how alterations in the urinary and GI microbiota and associated metabolites impact on host immunity after renal transplantation, and (b) whether such changes are correlated with post-transplant complications, such as rejection, development of de novo donor specific antibodies, metabolic complications (e.g post-transplant diabetes) and infections. Participants will be followed before and up to twelve months post-transplantation, and, longitudinal microbial data will be correlated with in-depth immune phenotyping and clinical end-points to define the impact that changes in urinary and GI microbial ecology have on kidney transplant outcomes.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Kidney transplant live-donor
Participants that will be a planned live renal transplant donor
Pre-operative assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing
Post-operative day 3 assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative week 4-6 assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative 3 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Pre-operative 6 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative month 12 recipient assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Kidney transplant recipient
Renal transplant recipient on the waiting list to have or will have had an ABO-blood group compatible live-donor or cadaveric transplant
Pre-operative assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing
Post-operative week 4-6 assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative 3 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Pre-operative 6 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative month 12 recipient assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Interventions
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Pre-operative assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing
Post-operative day 3 assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative week 4-6 assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative 3 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Pre-operative 6 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Post-operative month 12 recipient assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
Urine and faecal samples for 16S rRNA gene sequencing.
Eligibility Criteria
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Inclusion Criteria
1. Participant able to give Informed Consent
2. All patients will be at least 18 years old
3. Patients will either be a live renal transplant donor or a renal transplant recipient on the waiting list to have or will have had an ABO-blood group compatible renal transplant.
4. Patients attending hospital clinics at participating centre for routine clinical follow -up.
5. Patients willing to comply with study procedures and willing to provide blood, faecal and urine samples.
Exclusion Criteria
2. Patients unable to give informed consent
3. Patients not able to comply with study procedures or follow-up visits
4. Patients that are not a live renal donor or that are not on the waiting list to have or have not had an ABO blood group compatible renal transplant and are not attending hospital outpatient clinics at participating study centres for routine clinical follow-up.
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Royal Free Hospital NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Research and Development Manager
Role: STUDY_CHAIR
Sponsor GmbH
Locations
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Royal Free London NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Reza Motallebzadeh, PhD FRCS
Role: primary
Amanda Bidle
Role: backup
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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125570
Identifier Type: -
Identifier Source: org_study_id