Transplant ComplicationProtect_ChildNCT07194057
"A Privacy-protecting Environment for Child Transplants Health Related and Genomic Data Integration in the European Reference Network"
An observational study of Transplant Complication and Kidney Transplant, run by Instituto de Investigación Hospital Universitario La Paz at 4 sites in 3 countries.
Trial summary
Protect_Child_101 is an observational study to be performed in children that have undergone a liver or renal transplant. The aim of this study is to analyse small variations in the genetic material (DNA) of transplanted children. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Transplant Complication, Kidney Transplant, Liver Transplant
- What is being tested?
- Whole genome sequencing, Polygenic Risk Score Calculation and Methylome and episignatures
- How many people
- 200 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 Sep 2025to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will enroll paediatric patients that have underdone a renal i liver transplant
Who may be able to join
- ● Paediatric patients (6 months to 18 years old) with liver or kidney transplant.
- Both patients with de novo transplantation or in follow-up can be included in the study.
- For the retrospective cohort, only patients within the first 5 years after transplantation will be included.
- Patients and/or parents agreeing to participate in the study and provide consent for the obtention of clinical data and samples for genomic and methylomic analysis and the use of the information according to the protocol.
Who cannot join
- Patients that are not being followed up in the clinical site.
- Subjects alternating between different clinical sites. Subjects/Tutors that don't understand the informed consent form.
- Subject or their legally authorized representative does not sign the informed consent document.
- Re-transplantation or AB0-incompatible transplantation.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Italy2 sites
University Hospital Padova
Padova, 35128
Mara Cananzi, 049-821.1662, gastroenterologia.pediatrica@aopd.veneto.it
Mediterranean Institute for Transplantation (ISMETT)
Palermo, Sicily, 90127
Giusy Ranucci, MD, +39 912192111, granucci@ismett.edu
Germany1 site
University Medical Center Hamburg-Eppendorf (UKE),
Hamburg, 20251
Jan Beime, MD, +49 40 74100, j.beime@uke.de
Spain1 site
Hospital Universitario La Paz
Madrid, Madrid, 28046
Paula Valle Simón, PhD, pvalle@salud.madrid.org
About this study
Protect_Child_101 is an observational study to be performed in children that have undergone a liver or renal transplant.
The aim of this study is to analyse small variations in the genetic material (DNA) of transplanted children. The investigators will also study a type of chemical 'marks' called methylations, which do not change the DNA itself, but can affect how it functions. These marks can influence how certain diseases develop or how the body responds to transplantation.
Read more
Specifically, investigators seek to discover:
- Whether there are genetic or epigenetic (methylation) alterations that may explain why some children develop serious diseases that require transplantation.
- If these alterations can help us predict possible complications after transplantation, such as organ rejection, infections, organ failure, cancer development.
Within this study, data from the child's medical history will be collected. The data to be collected are demographic data (gender, age, ethnicity), clinical data, personal and family history possibly related to his/her disease, course and evolution of the disease, and complementary and laboratory examinations collected from his/her clinical history.
The only non-routine tests to be performed will be the genomic and methylomic tests. Nevertheless, these determinations will be performed on samples obtained during the child's routine care. No extra intervention is planned as part of this study.
Samples and clinical data will be collected at different time points after transplantation. Schematically, collection is planned for months 0, 1, 3, 6, 12 and 24 post-transplant. In addition to these pre-established points, comprehensive data collection will be attempted when the child suffers a relevant clinical event, e.g. infection, treatment toxicity, organ rejection (post-transplant complication).
- Conditions
- Transplant Complication, Kidney Transplant, Liver Transplant
- Being tested
- Whole genome sequencing, Polygenic Risk Score Calculation, Methylome and episignatures
- Keywords
- observational, epigenomic analysis, genomic analysis, european health data space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole genome sequencingGenetic
Also called Methylomic array, Polygenic risk score
Whole genome sequencing (WGS) is an advanced genomic technique that allows for the comprehensive analysis of an individual's entire DNA sequence, including both coding and non-coding regions. In the context of pediatric transplantation, WGS offers a powerful tool for uncovering underlying genetic disorders that may influence transplant eligibility, donor-recipient compatibility, immune response, or risk of post-transplant complications. It enables the identification of rare monogenic diseases, pharmacogenomic markers relevant to immunosuppressive therapy, and potential genetic predispositions to graft rejection or infection. Integrating WGS into transplant evaluation process enhances personalized medicine approaches, contributing to improved long-term outcomes in pediatric transplant recipients.
Polygenic Risk Score CalculationGenetic
A polygenic risk score (PRS) calculation will be performed to quantitatively estimate the an individual's genetic predisposition to the original disease that led to transplantation. These scores are calculated by aggregating the weighted sum of risk alleles-most commonly single nucleotide polymorphisms (SNPs)-each of which contributes a small effect size as determined by genome-wide association studies (GWAS).
Methylome and episignaturesDiagnostic test
Methylomic analysis in paediatric transplantation refers to the comprehensive profiling and study of DNA methylation patterns across the genome to understand epigenetic modifications associated with transplant-related outcomes.
This epigenetic approach enables the identification of differentially methylated regions (DMRs) that may correlate with clinical phenotypes, such as graft acceptance or rejection, infectious complications, or immune dysregulation.
The studies withjin the Protect_Child_101 project will be aimed at: 1) Refinement of episignatures, to increase specificity, sensitivity and robustness of those episignatures that already exist and 2) Discovery and validation of new disease, gene or variant specific mDNA signatures.
| Study group | Role | What they receive |
|---|---|---|
| Paediatric kidney and liver transplant that suffered a clinical event of interest after transplant | This cohort is made up of paediatric kidney and liver patients that had a clinical event after transplantation. The main clinical events of interest of this study are: viral infections, bacterial infections, drug-related toxicity and rejection. All patients will undergo genomic and methylomic tests to diagnose biological risk factors that could help determine the risk of developing the clinical event of interest. Receives: Genetic: Whole genome sequencing; Genetic: Polygenic Risk Score Calculation; Diagnostic Test: Methylome and episignatures | |
| Paediatric kidney and liver transplant patients with no events after transplant | This cohort is made up of paediatric kidney and liver patients that did not develop a clinical event after transplantation. All patients will undergo genomic and methylomic tests. The genetic and methylomic results will be compared to those of the patients that developed a clinical event. The objetive is to identify biological risk factors that could help determine the risk of developing the clinical event of interest. Receives: Genetic: Whole genome sequencing; Genetic: Polygenic Risk Score Calculation; Diagnostic Test: Methylome and episignatures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epstein Barr Infection
Number of Espstein Barr infections defined as >3500 copies in PCR in peripheral blood
Measured: From transplant until end of post-transplant follow-up period (up to 7years)
Cytomegalovirus infection
- Primary CMV infection after transplant with or without CMV disease (>1000 copies/ml in peripheral blood in patients with previous negative CMV serology) B) Secondary CMV infection after transplant (any PCR with CMV disease or CMV >1000 copies/ml in asymptomatic patients)
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
BK virus infection
Positive BK viremia (define cut-off level) and/or histological evidence of BK nephropathy
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Cholangitis
Worsening of liver function tests accompanied by an elevation in inflammatory markers, with or without a positive blood or bile culture.
Measured: From transplant until end of post-transplant follow-up period
Urinary Tract Infection
Positive urine cultures AND increased inflammation marker (e.g. CRP) or fever
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Sepsis
SIRS in relation to infectious cause +/- positive blood cultures
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Renal Calcineurin Inhibitors toxicity
Histological evidence of kidney CNI-related kidney damage
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Mycophenolate mofetil toxicity
Evidence of myelosuppression during therapy without any other proven cause and/or Clinical/histological evidence of MMF-related enteropathy
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
mTOR inhibitor toxicity
mTOR induced-proteinuria (occurrence of proteinuria after mTOR exposure with resolution after treatment suspension)
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Thrombotic microangiopathy
Ocurrence of no non immune-mediated hemolytic anemia and/or thrombocytopenia and/or hypertension and/or proteinuria with histological evidence of kidney TMA
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Kidney rejection episode
Histological evidence based on Banff criteria
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Liver rejection episode
Histological evidence based on Banff criteria
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Chronic liver rejection
Histological evidence based on Banff criteria
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Chronic kidney rejection
Histological evidence based on Banff criteria
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Chronic renal failure after pLTx
Elevation of serum-creatinine for 3>months
Measured: From transplant until end of post-transplant follow up period (up to 7 years)
Chronic liver failure (graft chirrosis and fibrosis)
Ocurrence of portal hypertension diagnosis both clinical (ascites, splenomegaly, varices) and analytical (thrombocytopenia) presentation.
Measured: From transplant until end of post-transplant follow up period (up to 7 years)
Secondary outcomes (17)
Liver Primary non-function
Requirement for immediate re-transplantation
Measured: From transplant to post-trasnplant follow-up period (up to 7 years)
Liver Primary non-function
Early death within the first 7 or 14 days following LT after exclusion of other identifiable causes of graft function such as vascular complications, rejection, or infection
Measured: From transplant to post-transplant follow-up period (up to 7 years)
Liver Primary non-function
Ocurrence of at least 2 of the following within 7 days post-transplant:
- Alanine aminotransferase (ALT) greater than or equal to 2,000 U/L
- INR greater than or equal to 10 mg/dl
- Acidosis (Defined as one of the following: a) Arterial PH less or equal to 7,30. b) Venous pH less than or equal to 7,25. c) Lactate greater than or equal to 4 mmol/L)
Measured: From transplant to post-trasnplant follow-up period (up to 7 years)
Kidney primary non-function
Persistence of dialysis status or eGFR <15 ml/min/1.7 m2
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Liver early allograft dysfunction
One of the following laboratory criteria within the 7 first days post transplant:
- Serum bilirubin ≥10 mg/dL (171 μmol/L) on day 7
- INR ≥1.6 on day 7
- AST or ALT >2000 IU/L within the first 7 days.
Or, for 5 consecutive days after day 7:
- Bilirubin > 10 mg/ dL
- INR > 1.6
- Serum Urea > 100 mg/dL
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Delayed kidney Graft Function
Need for dialysis within the first 7 days after kidney transplantation
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Vascular Complications
Hepatic artery thrombosis (HAT) or portal vein stenosis (may lead to ischemic injury and chronic dysfunction)
Measured: From transplant until end of post-transplant follow-up period (Up to 7 years)
Biliary Complications
Biliary structures, leaks, or ischemic cholangiopathy due to vascular insufficiency can cause chronic dysfunction.
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Urological complications
Need of re-intervention due to post-surgical events
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Post-transplant lymphoproliferative disease
Histological diagnosis of PTLD: histology, immunohistochemistry, EBV detection (EBER in situ hybridization), and clonality studies, classified according to WHO PTLD categories.
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Post-transplant lymphoproliferative disease
Radiological diagnosis of PTLD: heterogeneous extranodal masses, allograft involvement, and CNS or visceral lesions.
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Diabetes
The diagnosis is confirmed when one of the following criteria is met on two separate occasions:
Fasting plasma glucose (FPG): ≥126 mg/dL (7.0 mmol/L) after at least 8 hours fasting.
Oral glucose tolerance test (OGTT): 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) after a 75 g oral glucose load.
Hemoglobin A1c (HbA1c): ≥6.5%, using a standardized assay.
Random plasma glucose: ≥200 mg/dL (11.1 mmol/L) in the presence of classic symptoms of hyperglycemia (polyuria, polydipsia, weight loss).
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Posterior reversible encelopathy (PRES)
Ocurrence of acute neurologic symptoms (headache, seizures, altered consciousness or visual disturbances) with typical neuroimaging (CT, MRI) findings (bilateral areas of white matter edema in the posterior cerebral hemispheres).
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Mortality
Death by any cause
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Relapse of primary immune mediated disease
Ocurrence of nephrotic range proteinuria after kidney transplant (excluding other causes)
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Relapse of primary immune mediated disease
histological findings of Focal segmental glomerulosclerosis (FSGS) in kidney biopsy in a patient with primary FSGS
Measured: From transplant until end of post-transplant follow-up period (up to 7 years)
Graft survival
Time from transplant to the need for dialysis or entry onto the re- transplant list.
Measured: From transplant until end of post-transplant follow-up period (up 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant ComplicationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194057
- Sponsor's protocol ID
- PI-6796
- Acronym
- Protect_Child
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 26 Sep 2025
- 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 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Privacy-protecting Environment for Child Transplants Health Related and Genomic Data Integration in the European Reference Network"
- ClinicalTrials.gov ID
- NCT07194057
- Acronym / sponsor ID
- Protect_Child / PI-6796
- Conditions
- Transplant Complication, Kidney Transplant, Liver Transplant
- Keywords
- observational, epigenomic analysis, genomic analysis, european health data space
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 Sep 2025 (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.
Protect_Child_101 is an observational study to be performed in children that have undergone a liver or renal transplant.
The aim of this study is to analyse small variations in the genetic material (DNA) of transplanted children. The investigators will also study a type of chemical 'marks' called methylations, which do not change the DNA itself, but can affect how it functions. These marks can influence how certain diseases develop or how the body responds to transplantation.
Specifically, investigators seek to discover:
- Whether there are genetic or epigenetic (methylation) alterations that may explain why some children develop serious diseases that require transplantation.
- If these alterations can help us predict possible complications after transplantation, such as organ rejection, infections, organ failure, cancer development.
Within this study, data from the child's medical history will be collected. The data to be collected are demographic data (gender, age, ethnicity), clinical data, personal and family history possibly related to his/her disease, course and evolution of the disease, and complementary and laboratory examinations collected from his/her clinical history.
The only non-routine tests to be performed will be the genomic and methylomic tests. Nevertheless, these determinations will be performed on samples obtained during the child's routine care. No extra intervention is planned as part of this study.
Samples and clinical data will be collected at different time points after transplantation. Schematically, collection is planned for months 0, 1, 3, 6, 12 and 24 post-transplant. In addition to these pre-established points, comprehensive data collection will be attempted when the child suffers a relevant clinical event, e.g. infection, treatment toxicity, organ rejection (post-transplant complication).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paediatric kidney and liver transplant that suffered a clinical event of interest after transplant | – | Genetic: Whole genome sequencing, Genetic: Polygenic Risk Score Calculation, Diagnostic Test: Methylome and episignaturesThis cohort is made up of paediatric kidney and liver patients that had a clinical event after transplantation. The main clinical events of interest of this study are: viral infections, bacterial infections, drug-related toxicity and rejection. All patients will undergo genomic and methylomic tests to diagnose biological risk factors that could help determine the risk of developing the clinical event of interest. |
| Paediatric kidney and liver transplant patients with no events after transplant | – | Genetic: Whole genome sequencing, Genetic: Polygenic Risk Score Calculation, Diagnostic Test: Methylome and episignaturesThis cohort is made up of paediatric kidney and liver patients that did not develop a clinical event after transplantation. All patients will undergo genomic and methylomic tests. The genetic and methylomic results will be compared to those of the patients that developed a clinical event. The objetive is to identify biological risk factors that could help determine the risk of developing the clinical event of interest. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will enroll paediatric patients that have underdone a renal i liver transplant
Key inclusion criteria (4 listed)
- ● Paediatric patients (6 months to 18 years old) with liver or kidney transplant.
- Both patients with de novo transplantation or in follow-up can be included in the study.
- For the retrospective cohort, only patients within the first 5 years after transplantation will be included.
- Patients and/or parents agreeing to participate in the study and provide consent for the obtention of clinical data and samples for genomic and methylomic analysis and the use of the information according to the protocol.
Key exclusion criteria (4 listed)
- Patients that are not being followed up in the clinical site.
- Subjects alternating between different clinical sites. Subjects/Tutors that don't understand the informed consent form.
- Subject or their legally authorized representative does not sign the informed consent document.
- Re-transplantation or AB0-incompatible transplantation.
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 |
|---|---|---|
| Whole genome sequencingAlso: Methylomic array, Polygenic risk scoreWhole genome sequencing (WGS) is an advanced genomic technique that allows for the comprehensive analysis of an individual's entire DNA sequence, including both coding and non-coding regions. In the context of pediatric transplantation, WGS offers a powerful tool for uncovering underlying genetic disorders that may influence transplant eligibility, donor-recipient compatibility, immune response, or risk of post-transplant complications. It enables the identification of rare monogenic diseases, pharmacogenomic markers relevant to immunosuppressive therapy, and potential genetic predispositions to graft rejection or infection. Integrating WGS into transplant evaluation process enhances personalized medicine approaches, contributing to improved long-term outcomes in pediatric transplant recipients. | Genetic | Paediatric kidney and liver transplant patients with no events after transplant, Paediatric kidney and liver transplant that suffered a clinical event of interest after transplant |
| Polygenic Risk Score CalculationA polygenic risk score (PRS) calculation will be performed to quantitatively estimate the an individual's genetic predisposition to the original disease that led to transplantation. These scores are calculated by aggregating the weighted sum of risk alleles-most commonly single nucleotide polymorphisms (SNPs)-each of which contributes a small effect size as determined by genome-wide association studies (GWAS). | Genetic | Paediatric kidney and liver transplant patients with no events after transplant, Paediatric kidney and liver transplant that suffered a clinical event of interest after transplant |
| Methylome and episignaturesMethylomic analysis in paediatric transplantation refers to the comprehensive profiling and study of DNA methylation patterns across the genome to understand epigenetic modifications associated with transplant-related outcomes. This epigenetic approach enables the identification of differentially methylated regions (DMRs) that may correlate with clinical phenotypes, such as graft acceptance or rejection, infectious complications, or immune dysregulation. The studies withjin the Protect_Child_101 project will be aimed at: 1) Refinement of episignatures, to increase specificity, sensitivity and robustness of those episignatures that already exist and 2) Discovery and validation of new disease, gene or variant specific mDNA signatures. | Diagnostic test | Paediatric kidney and liver transplant patients with no events after transplant, Paediatric kidney and liver transplant that suffered a clinical event of interest after transplant |
Primary outcome
Epstein Barr Infection
Time frame: From transplant until end of post-transplant follow-up period (up to 7years)
Number of Espstein Barr infections defined as >3500 copies in PCR in peripheral blood
Cytomegalovirus infection
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
A) Primary CMV infection after transplant with or without CMV disease (>1000 copies/ml in peripheral blood in patients with previous negative CMV serology) B) Secondary CMV infection after transplant (any PCR with CMV disease or CMV >1000 copies/ml in asymptomatic patients)
BK virus infection
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Positive BK viremia (define cut-off level) and/or histological evidence of BK nephropathy
Cholangitis
Time frame: From transplant until end of post-transplant follow-up period
Worsening of liver function tests accompanied by an elevation in inflammatory markers, with or without a positive blood or bile culture.
Urinary Tract Infection
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Positive urine cultures AND increased inflammation marker (e.g. CRP) or fever
Sepsis
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
SIRS in relation to infectious cause +/- positive blood cultures
Renal Calcineurin Inhibitors toxicity
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Histological evidence of kidney CNI-related kidney damage
Mycophenolate mofetil toxicity
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Evidence of myelosuppression during therapy without any other proven cause and/or Clinical/histological evidence of MMF-related enteropathy
mTOR inhibitor toxicity
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
mTOR induced-proteinuria (occurrence of proteinuria after mTOR exposure with resolution after treatment suspension)
Thrombotic microangiopathy
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Ocurrence of no non immune-mediated hemolytic anemia and/or thrombocytopenia and/or hypertension and/or proteinuria with histological evidence of kidney TMA
Kidney rejection episode
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Histological evidence based on Banff criteria
Liver rejection episode
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Histological evidence based on Banff criteria
Chronic liver rejection
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Histological evidence based on Banff criteria
Chronic kidney rejection
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Histological evidence based on Banff criteria
Chronic renal failure after pLTx
Time frame: From transplant until end of post-transplant follow up period (up to 7 years)
Elevation of serum-creatinine for 3>months
Chronic liver failure (graft chirrosis and fibrosis)
Time frame: From transplant until end of post-transplant follow up period (up to 7 years)
Ocurrence of portal hypertension diagnosis both clinical (ascites, splenomegaly, varices) and analytical (thrombocytopenia) presentation.
17 secondary outcomes
Liver Primary non-function
Time frame: From transplant to post-trasnplant follow-up period (up to 7 years)
Liver Primary non-function
Time frame: From transplant to post-transplant follow-up period (up to 7 years)
Liver Primary non-function
Time frame: From transplant to post-trasnplant follow-up period (up to 7 years)
Kidney primary non-function
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Liver early allograft dysfunction
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Delayed kidney Graft Function
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Vascular Complications
Time frame: From transplant until end of post-transplant follow-up period (Up to 7 years)
Biliary Complications
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Urological complications
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Post-transplant lymphoproliferative disease
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Post-transplant lymphoproliferative disease
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Diabetes
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Posterior reversible encelopathy (PRES)
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Mortality
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Relapse of primary immune mediated disease
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Relapse of primary immune mediated disease
Time frame: From transplant until end of post-transplant follow-up period (up to 7 years)
Graft survival
Time frame: From transplant until end of post-transplant follow-up period (up 7 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- 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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Complication and Kidney Transplant, run by Instituto de Investigación Hospital Universitario La Paz at 4 sites in 3 countries.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Germany, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Valle Simon, PhD (914975485, pvalle@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epstein Barr Infection (time frame: From transplant until end of post-transplant follow-up period (up to 7years)). The study lists 16 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 26 Sep 2025.