Liver Transplant RejectionNCT06060808
Role of NFKBIA and PTPN22 Genes Polymorphism in Acute Rejection Susceptibility After Living Donor Liver Transplantation in Egyptian Patients.
An observational study of Liver Transplant Rejection, run by Helwan University at 1 site in Egypt.
Trial summary
Our study aimed at studying the impact of gene polymorphism of NFKBIA and PTPN22 genes on rejection episodes in liver transplant Egyptian recipients. Also assess patients' factors associated with graft rejection. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Liver Transplant Rejection
- What is being tested?
- gene polymorphism
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 24 Jul 2023
- How long will I take part?
- 2 Years
- 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 20 to 64 years
- All sexes
- Adult
Study population: Adult patients with end stage liver disease(ESLD) underwent living donor liver transplantation were recruited from Ain Shams University hospitals, Cairo, Egypt.
Who may be able to join
- Adult Patients with ESLD were subjected to living donor liver transplantation due to different etiologies including hepatitis C virus (HCV), hepatitis B virus (HBV), autoimmune hepatitis (AIH), portal venous thrombosis (PVT), cryptogenic hepatitis, Primary sclerosing cholangitis(PSC), hepatocellular and carcinoma(HCC) were eligible for the study. Recipients received calcineurin inhibitors either tacrolimus or cyclosporine as primary immunosuppressant ± MMF or evorilumus ± MMF immediately after transplantation.
Who cannot join
- Patients were excluded if they had multi-organ transplantation, had previously received a liver transplant, or were receiving an ABO-incompatible transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Our study aimed at studying the impact of gene polymorphism of NFKBIA and PTPN22 genes on rejection episodes in liver transplant Egyptian recipients. Also assess patients' factors associated with graft rejection.
Read the detailed description
Liver transplantation is considered an effective therapy for severe liver disease, but graft dysfunction occurs in up to 13% of patients during the first year following transplantation, and rises to 35% after 5 years (Keeffe, 1999; Yu et al., 2001). Graft rejection is one of the major immunological complications following liver transplantation (Zheng et al., 2006).
The nuclear factor of kappa light polypeptide gene enhancer B-cells inhibitor-alpha (NFKBIA) gene encodes a member of the nuclear factor-kappa-B inhibitor family. Polymorphisms in this gene might be associated with a susceptibility to acute rejection episodes following liver transplantation, as they may cause an increased activation level of the proinflammatory transcription factor nuclear factor of kappa light polypeptide gene enhancer in B-cells (NFκB).
NFκB translocates to the nucleus and promotes the expression of a panel of genes (Karin and Ben-Neriah, 2000). Some of these, for example interleukin-2, interleukin-6, interleukin-12 or tumor necrosis factor-alpha, play an important role in the pathogenesis of allograft rejection and the activation of the immune system in general (Wei and Zheng, 2003).
The protein tyrosine phosphatase nonreceptor 22 gene (PTPN22) encodes a strong T-cell regulator called lymphoid protein tyrosine phosphatase. Previously, PTPN22 was described as a susceptibility gene for autoimmunity because it contains single nucleotide polymorphisms (SNPs) associated with several autoimmune diseases. One SNP (rs2476601;1858G>A) has emerged as a particularly potent risk factor for autoimmunity. We address the question whether PTPN22 polymorphismsare also associated with acute rejection after liver transplantation. (Dullin et al., 2015).
- Conditions
- Liver Transplant Rejection
- Being tested
- gene polymorphism
- Keywords
- gene polymorphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene polymorphismGenetic
gene polymorphism of NFKBIA and PTPN22 genes
What is being measured
The primary outcome is the main question the study is designed to answer.
gene polymorphism
gene polymorphism of NFKBIA and PTPN22 genes
Measured: baseline
Secondary outcomes (1)
immunosuppressant levels
tacrolimus,cycosporin,evrolimus trough levels
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start15 Mar 2021
- Primary completion23 Apr 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RejectionStudies 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
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Mohamed Abdel Motaleb, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060808
- Sponsor's protocol ID
- gene polymorphism
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of NFKBIA and PTPN22 Genes Polymorphism in Acute Rejection Susceptibility After Living Donor Liver Transplantation in Egyptian Patients.
- ClinicalTrials.gov ID
- NCT06060808
- Acronym / sponsor ID
- gene polymorphism
- Conditions
- Liver Transplant Rejection
- Keywords
- gene polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 29 Sep 2023 (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.
Our study aimed at studying the impact of gene polymorphism of NFKBIA and PTPN22 genes on rejection episodes in liver transplant Egyptian recipients. Also assess patients' factors associated with graft rejection.
Detailed description
Liver transplantation is considered an effective therapy for severe liver disease, but graft dysfunction occurs in up to 13% of patients during the first year following transplantation, and rises to 35% after 5 years (Keeffe, 1999; Yu et al., 2001). Graft rejection is one of the major immunological complications following liver transplantation (Zheng et al., 2006).
The nuclear factor of kappa light polypeptide gene enhancer B-cells inhibitor-alpha (NFKBIA) gene encodes a member of the nuclear factor-kappa-B inhibitor family. Polymorphisms in this gene might be associated with a susceptibility to acute rejection episodes following liver transplantation, as they may cause an increased activation level of the proinflammatory transcription factor nuclear factor of kappa light polypeptide gene enhancer in B-cells (NFκB).
NFκB translocates to the nucleus and promotes the expression of a panel of genes (Karin and Ben-Neriah, 2000). Some of these, for example interleukin-2, interleukin-6, interleukin-12 or tumor necrosis factor-alpha, play an important role in the pathogenesis of allograft rejection and the activation of the immune system in general (Wei and Zheng, 2003).
The protein tyrosine phosphatase nonreceptor 22 gene (PTPN22) encodes a strong T-cell regulator called lymphoid protein tyrosine phosphatase. Previously, PTPN22 was described as a susceptibility gene for autoimmunity because it contains single nucleotide polymorphisms (SNPs) associated with several autoimmune diseases. One SNP (rs2476601;1858G>A) has emerged as a particularly potent risk factor for autoimmunity. We address the question whether PTPN22 polymorphismsare also associated with acute rejection after liver transplantation. (Dullin et al., 2015).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adult patients with end stage liver disease(ESLD) underwent living donor liver transplantation were recruited from Ain Shams University hospitals, Cairo, Egypt.
Key inclusion criteria (1 listed)
- Adult Patients with ESLD were subjected to living donor liver transplantation due to different etiologies including hepatitis C virus (HCV), hepatitis B virus (HBV), autoimmune hepatitis (AIH), portal venous thrombosis (PVT), cryptogenic hepatitis, Primary sclerosing cholangitis(PSC), hepatocellular and carcinoma(HCC) were eligible for the study. Recipients received calcineurin inhibitors either tacrolimus or cyclosporine as primary immunosuppressant ± MMF or evorilumus ± MMF immediately after transplantation.
Key exclusion criteria (1 listed)
- Patients were excluded if they had multi-organ transplantation, had previously received a liver transplant, or were receiving an ABO-incompatible transplant.
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 |
|---|---|---|
| gene polymorphismgene polymorphism of NFKBIA and PTPN22 genes | Genetic | – |
Primary outcome
gene polymorphism
Time frame: baseline
gene polymorphism of NFKBIA and PTPN22 genes
1 secondary outcome
immunosuppressant levels
Time frame: 14 days
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 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Transplant Rejection, run by Helwan University at 1 site in Egypt.
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 1 inclusion and 1 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 Sep 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 Egypt. 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?
gene polymorphism (time frame: baseline). 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 Sep 2023.