- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05894993
Transient Elastograghy to Detect Non Alcoholic Fatty Liver Disease in Renal Transplantation Recipients.
Transient Elastograghy to Detect NAFLD in RTRs
Study Overview
Status
Intervention / Treatment
Detailed Description
. Nonalcoholic fatty liver disease is caused by an accumulation of fat in the liver in the absence of significant alcohol intake. Nonalcoholic fatty liver disease is the most common chronic liver disorder. Chronic kidney disease defined as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1•73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause.
Nonalcoholic fatty liver disease (and chronic kidney disease constitute a global public health problem, affecting approximately 25% and 10% of the world population, respectively. In recent years, both Nonalcoholic fatty liver disease and chronic kidney disease have shown increasing incidences.
Renal transplantation has significantly improved the survival of patients with end-stage renal disease (ESRD). Despite major advancements in immunosuppressive treatment of renal transplant recipients (RTR) that significantly increased graft and patient short-term survival and lowered the incidence of rejection crises, long-term prognosis is still poor. ., Immunosuppressive drugs used in renal trasplantation increase incidence and severity of traditional cardiovascular risk factors and thus have expected effects on components of the metabolic syndrome (MS) after kidney transplantation. Other Common factors underlying the pathogenesis of and chronic allograft dysfunction may be insulin resistance, oxidative stress, activation of rennin-angiotensin system , Dyslipidemia, and inappropriate secretion of inflammatory cytokines by stereogenic and inflamed liver.
NAFLD represents a liver manifestation of metabolic syndrome and it development is strongly associated with all components of MS in general population. They propose that the presence of NAFLD in RTR could be a strong predictor in cardiovascular morbidity and mortality., Wang H, Lin ZT, Yuan Y, Wu T. hypothesis that non alcoholic fatty liver disease may be associated with deteriorating graft function, causing a chronic allograft nephropathy and graft loss.
Due to the high rate of corticosteroid askwith considering the strong relationship between chronic kidney disease and NAFLD, NAFLD would probably be a common disorder among kidney transplantation recipients if these patients did not receive stereogenic medications.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amany khaled Ahmed, master
- Phone Number: +201122620076
- Email: amany.khaled91@med.aun.edu.eg
Study Contact Backup
- Name: Effat TONY, MD
- Phone Number: +201097330309
- Email: effattony@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
• a. Inclusion criteria: All renal transplant recipients with a functioning graft for more than 1 year coming for follow up at renal outpatient clinics in Assiut university hospitals .
- Trough level of immunosuppressive drugs .
Exclusion Criteria:
Patients are excluded for participation in the study if
- chronic hepatitis B and/or C virus infection,
- CMV infections
- Chronic liver disease
- presence of other autoimmune or cholestatic liver disease,
- drug induced liver disorder
- excessive alcohol abuse,
- pregnancy
- malignancy
- dyslipidemia, bleeding tendency ,
- Renal rejections .
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
): The presence of NAFLD in post renal transplantation recipients by non invasive methods as transient elastograghy.
Time Frame: Degree of hepatic fibroses from f0-f4,Degree of steatosis "through study completion, an average of 1 year"
|
): to evaluate if transient elastograghy could be used as a noninvasive tool as new perspective on the prediction, prevention of non alcoholic fatty liver desease in renal trasplantation recipients .
|
Degree of hepatic fibroses from f0-f4,Degree of steatosis "through study completion, an average of 1 year"
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAFLD in RTRs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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