Renal TransplantationNCT05208788
Urinary Biomarkers in Paediatric Kidney Transplantation (pKTx)
An observational study of Renal Transplantation and Chronic Kidney Insufficiency, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may… Read more about this study
- Who is it for?
- Ages 0 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplantation, Chronic Kidney Insufficiency, Healthy Controls
- What is being tested?
- Biomarker test
- Type of treatment
- Injection or infusion
- How many people
- 186 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children < 18 years
Who may be able to join
- Group 1 (patients < 18 years of age)- obtaining reference values without any of the pre-defined events
- renal transplant patients with stable renal function parameters (mean SCr (or cystatin C) or mean eGFR based on creatinine and / or cystatin C defined as changes ≤ ±15 % for at least three consecutive ambulatory controls).
- patients with CKD IV-V (and maintained urine output, without renal replacement therapy and without pre-defined events).
- healthy controls.
- Study patients from group 1 may be assigned to the group 2 in the following conditions:
- Group 2 (patients < 18 years of age)- obtaining biomarker-specific characteristic in the presence of any of the pre-defined events
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- renal transplant recipients with living or deceased kidney transplantation.
- patients with CKD IV-V (and maintained urine output without renal replacement therapy).
- healthy controls.
Who cannot join
- Healthy controls
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. primary kidney or liver disease, metabolic disease, vasculitis or other immunological disease other than the pre-defined events).
- for group 1: presence of any of the pre-defined event. ii) CKD IV-V
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. liver disease, metabolic disease, vasculitis or other immunological disease other than the pre-defined events).
- for group 1: presence of any of the pre-defined event. iii) Renal transplant patients for group 1: presence of any of the pre-defined event.
- Primary non-function of the renal transplant organ.
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- Blood group (AB0) incompatible.
- Detection of donor specific antibody (DSA) positive (panel-reactive antibodies) at time of enrolment.
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. liver disease, metabolic disease, vasculitis or other immunological disease) other than the pre-defined events.
- Presence of other transplanted organs or co-transplanted organs.
- Intention to not use a standard maintenance immunosuppression regimen consisting of calcineurin inhibitor (CNI), antimetabolite (mycophenolate or azathioprine), inhibitor of mechanistic target of rapamycin (mTOR) (Sirolimus / Everolimus) with/without corticosteroids.
- Any condition that, in the opinion of the investigator, would pose risk to the subject's safe participation, or interfere with their ability to comply with the study requirements, or may impact the quality of the interpretation of the data (e.g. detection of malignancy).
- Failure to collect urine samples or incomplete additional CERTAIN dataset (for collecting information about pre-defined events).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Kidney Function Through a Combination of Renal Urinary Biomarkers in Paediatric Renal Transplant Patients - A Multi-centre Prospective Observational Study
This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may be observed after event-specific injury, (3) differences between paediatric renal transplant patients with AR and other causes of AKI can be detected, and (4) stratification of renal transplant patients to different histological types of AR is possible.
Read the detailed description
Despite advances in kidney transplantation, acute rejection (AR) is one of the primary risk factors for allograft kidney injury and function deterioration, and may have a significant impact on long-term graft survival, particularly in paediatric renal transplant patients. Against the background of the limited availability of kidney donor organs, the early recognition of AR is of particular interest to improve long-term allograft survival. Renal allograft biopsy remains the current gold standard for the diagnosis of kidney transplant rejection. However, it is an invasive procedure associated with the risk of bleeding, infection of the renal allograft, arterio-venous fistula, introducing sampling error, and a large inter-observer variation. Therefore, urinary biomarkers from minimally invasive compartments would be helpful for the early detection of clinical rejection before graft functional decline occurs. The current standard monitoring of the renal transplant function includes measurements of serum-creatinine (SCr) levels, estimatedglomerular filtration rate (eGFR), and proteinuria. These markers exhibit a lack of sensitivity and specificity and are late indicators for molecular and cellular events following AR. Furthermore, conditions other than AR (viral and bacterial infection, calcineurin nephrotoxicity, acute ischemic injury) resemble similar morphological features within the renal allograft challenging detection and differentiation of the underlying process. Early treatment of AR could lead to diminished histological injury and improved functional outcome. An intensified immunosuppression management represents the main strategy to counteract the uncontrolled attack of the recipient´s immune system against the renal allograft.
Not surprisingly, many attempts have been made to develop new biomarkers to improve the precision and accuracy in detecting AR for optimizing immunosuppression management. Because allograft reactive cells can gain access to the urinary space, urine represents an appropriate biospecimen to investigate allograft injury. The study urinary biomarkers have been partially discovered and characterized in the past for detection of acute kidney injury (AKI), rarely in renal transplant patients.
This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may be observed after event-specific injury, (3) differences between paediatric renal transplant patients with AR and other causes of AKI can be detected, and (4) stratification of renal transplant patients to different histological types of AR is possible.
- Being tested
- Biomarker test
- Keywords
- renal transplantation, biomarkers
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker testDiagnostic test
collection of 500µl to 1 ml of a spot urine sample
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant patients - group 1 | Renal transplant patients with stable renal function parameters (mean SCr (or cystatin C) or mean eGFR based on creatinine and / or cystatin C defined as changes ≤ ±15 % for at least three consecutive ambulatory controls). Receives: Diagnostic Test: Biomarker test | |
| renal transplant patients - group 2 | Renal transplant recipients with stable renal function at inclusion, facing a pre-defined event during the course of the study. Pre-defined events are Acute Rejection (AR), viral transplant-associated infection (e.g. BKV), bacterial infection (febrile urinary tract infection (fUTI)), calcineurin-inhibitor (CNI) toxicity, and acute tubular necrosis (ATN). Receives: Diagnostic Test: Biomarker test | |
| Patients with Chronic Kidney Disease Stage IV and V (CKD IV-V) - group 3 | Patients with CKD IV-V (and maintained urine output, without renal replacement therapy and without pre-defined events). Receives: Diagnostic Test: Biomarker test | |
| Healthy controls | Healthy children serve as control group Receives: Diagnostic Test: Biomarker test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum creatinine level [mg/dl]
Standard surveillance parameter of kidney function / renal allograft
Measured: from Baseline up to 18 months
Change of serum urea level [mg/dl]
Standard surveillance parameter of kidney function / renal allograft
Measured: from Baseline up to 18 months
Change of serum Cystatin C level [mg/l]
Standard surveillance parameter of kidney function / renal allograft
Measured: from Baseline up to 18 months
Measurement of urine creatinine level [g/l]
Standard surveillance parameter of renal function / renal allograft. All urinary study biomarkers (see below) will be correlated to urine creatinine level [ng/mg Creatinine] and compared with standard surveillance parameters of kidney function / renal allograft (see Outcome 1-3).
Measured: from Baseline up to 18 months
Change of urine alpha-1-Microglobulin (A1M)
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Aquaporin 2 (AQP2) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Caldesmon [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Clusterin [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Cystatin C [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Interleukin 9 (IL-9) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Kidney injury molecule 1 (Kim-1) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Nephrin [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Neutrophil gelatinase-associated lipocalin (NGAL) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Osteopontin (OPN) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine P-selectin (SELP) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Podocin [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Retinol-binding protein 4 (RBP4) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Smoothelin [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine Synaptopodin [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine tumour necrosis factor alpha (TNF-α) [ng/ml]
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Change of urine vascular cell adhesion molecule-1 (VCAM-1)
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Measured: from Baseline up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jun 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Natural and Medical Sciences Institute (NMI), Cooperative European Paediatric Renal Transplant Initiative (CERTAIN)
- Responsible party
- Sponsor
- Investigators
- Marcus Weitz, PD Dr. med., Principal investigator, University Children's Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208788
- Sponsor's protocol ID
- pKTx/318/2021BO1
- Status last verified
- Nov 2023
- First submitted
- 12 Jul 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Kidney Function Through a Combination of Renal Urinary Biomarkers in Paediatric Renal Transplant Patients - A Multi-centre Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05208788
- Acronym / sponsor ID
- pKTx/318/2021BO1
- Keywords
- renal transplantation, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Natural and Medical Sciences Institute (NMI), Cooperative European Paediatric Renal Transplant Initiative (CERTAIN)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may be observed after event-specific injury, (3) differences between paediatric renal transplant patients with AR and other causes of AKI can be detected, and (4) stratification of renal transplant patients to different histological types of AR is possible.
Detailed description
Despite advances in kidney transplantation, acute rejection (AR) is one of the primary risk factors for allograft kidney injury and function deterioration, and may have a significant impact on long-term graft survival, particularly in paediatric renal transplant patients. Against the background of the limited availability of kidney donor organs, the early recognition of AR is of particular interest to improve long-term allograft survival. Renal allograft biopsy remains the current gold standard for the diagnosis of kidney transplant rejection. However, it is an invasive procedure associated with the risk of bleeding, infection of the renal allograft, arterio-venous fistula, introducing sampling error, and a large inter-observer variation. Therefore, urinary biomarkers from minimally invasive compartments would be helpful for the early detection of clinical rejection before graft functional decline occurs. The current standard monitoring of the renal transplant function includes measurements of serum-creatinine (SCr) levels, estimatedglomerular filtration rate (eGFR), and proteinuria. These markers exhibit a lack of sensitivity and specificity and are late indicators for molecular and cellular events following AR. Furthermore, conditions other than AR (viral and bacterial infection, calcineurin nephrotoxicity, acute ischemic injury) resemble similar morphological features within the renal allograft challenging detection and differentiation of the underlying process. Early treatment of AR could lead to diminished histological injury and improved functional outcome. An intensified immunosuppression management represents the main strategy to counteract the uncontrolled attack of the recipient´s immune system against the renal allograft.
Not surprisingly, many attempts have been made to develop new biomarkers to improve the precision and accuracy in detecting AR for optimizing immunosuppression management. Because allograft reactive cells can gain access to the urinary space, urine represents an appropriate biospecimen to investigate allograft injury. The study urinary biomarkers have been partially discovered and characterized in the past for detection of acute kidney injury (AKI), rarely in renal transplant patients.
This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may be observed after event-specific injury, (3) differences between paediatric renal transplant patients with AR and other causes of AKI can be detected, and (4) stratification of renal transplant patients to different histological types of AR is possible.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Renal transplant patients - group 1 | – | Diagnostic Test: Biomarker testRenal transplant patients with stable renal function parameters (mean SCr (or cystatin C) or mean eGFR based on creatinine and / or cystatin C defined as changes ≤ ±15 % for at least three consecutive ambulatory controls). |
| renal transplant patients - group 2 | – | Diagnostic Test: Biomarker testRenal transplant recipients with stable renal function at inclusion, facing a pre-defined event during the course of the study. Pre-defined events are Acute Rejection (AR), viral transplant-associated infection (e.g. BKV), bacterial infection (febrile urinary tract infection (fUTI)), calcineurin-inhibitor (CNI) toxicity, and acute tubular necrosis (ATN). |
| Patients with Chronic Kidney Disease Stage IV and V (CKD IV-V) - group 3 | – | Diagnostic Test: Biomarker testPatients with CKD IV-V (and maintained urine output, without renal replacement therapy and without pre-defined events). |
| Healthy controls | – | Diagnostic Test: Biomarker testHealthy children serve as control group |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children < 18 years
Key inclusion criteria (9 listed)
- Group 1 (patients < 18 years of age)- obtaining reference values without any of the pre-defined events
- renal transplant patients with stable renal function parameters (mean SCr (or cystatin C) or mean eGFR based on creatinine and / or cystatin C defined as changes ≤ ±15 % for at least three consecutive ambulatory controls).
- patients with CKD IV-V (and maintained urine output, without renal replacement therapy and without pre-defined events).
- healthy controls.
- Group 2 (patients < 18 years of age)- obtaining biomarker-specific characteristic in the presence of any of the pre-defined events
Key exclusion criteria (13 listed)
- Healthy controls
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. primary kidney or liver disease, metabolic disease, vasculitis or other immunological disease other than the pre-defined events).
- for group 1: presence of any of the pre-defined event. ii) CKD IV-V
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. liver disease, metabolic disease, vasculitis or other immunological disease other than the pre-defined events).
- for group 1: presence of any of the pre-defined event. iii) Renal transplant patients for group 1: presence of any of the pre-defined event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker testcollection of 500µl to 1 ml of a spot urine sample | Diagnostic test | Healthy controls, Patients with Chronic Kidney Disease Stage IV and V (CKD IV-V) - group 3, Renal transplant patients - group 1, renal transplant patients - group 2 |
Primary outcome
Change of serum creatinine level [mg/dl]
Time frame: from Baseline up to 18 months
Standard surveillance parameter of kidney function / renal allograft
Change of serum urea level [mg/dl]
Time frame: from Baseline up to 18 months
Standard surveillance parameter of kidney function / renal allograft
Change of serum Cystatin C level [mg/l]
Time frame: from Baseline up to 18 months
Standard surveillance parameter of kidney function / renal allograft
Measurement of urine creatinine level [g/l]
Time frame: from Baseline up to 18 months
Standard surveillance parameter of renal function / renal allograft. All urinary study biomarkers (see below) will be correlated to urine creatinine level [ng/mg Creatinine] and compared with standard surveillance parameters of kidney function / renal allograft (see Outcome 1-3).
Change of urine alpha-1-Microglobulin (A1M)
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Aquaporin 2 (AQP2) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Caldesmon [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Clusterin [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Cystatin C [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Interleukin 9 (IL-9) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Kidney injury molecule 1 (Kim-1) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Nephrin [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Neutrophil gelatinase-associated lipocalin (NGAL) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Osteopontin (OPN) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine P-selectin (SELP) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Podocin [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Retinol-binding protein 4 (RBP4) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Smoothelin [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine Synaptopodin [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine tumour necrosis factor alpha (TNF-α) [ng/ml]
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Change of urine vascular cell adhesion molecule-1 (VCAM-1)
Time frame: from Baseline up to 18 months
Urinary study biomarker. The performance (sensitivity, specificity, positive predictive value and negative predictive value) for detection of kidney / graft deterioration will be calculated using receiver operator characteristics (ROC) curves.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Weitz, PD Dr. med. principal investigator
University Children's Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation and Chronic Kidney Insufficiency, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum creatinine level [mg/dl] (time frame: from Baseline up to 18 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.