Predictors of Outcome of Pediatric Renal Transplantation

November 26, 2024 updated by: Merna Nazeer,MD, Assiut University
Renal transplantation is a unique chance to a normal life for end-stage renal disease patients, because of the perfect morphological and functional replacement of the lost kidneys. Serum creatinine and proteinuria reflect kidney allograft function, but they are nonspecific tools.Imaging techniques plays an important role in the detection of anatomical as well as functional abnormalities in the early stages.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Renal transplantation is a unique chance to a normal life for end-stage renal disease patients, because of the perfect morphological and functional replacement of the lost kidneys. It is also the only effective way of replacement of the endocrine function of the kidneys. The survival of kidney grafts has improved considerably in recent years, due to advances in surgical techniques and in immunosupression protocols . Although improvements in surgical techniques and immunosuppression have led to longer survival, complications remain common, occurring in approximately 12%-20% of patients. Post transplantation complications can also be divided following the renal transplant's time of evolution into early complications (acute tubular necrosis, acute rejection, arterial or venous thrombosis, obstruction, urinary leak, post transplantation collections and infection) and late complications (transplant artery stenosis, arteriovenous fistulas, drugs toxicity, chronic rejection and urinary tract infection). Acute rejection (AR) is a major risk factor for chronic nephropathy and graft loss after renal transplantation (RT) . Antibody-mediated rejection (AMR) is the most common cause of allograft failure in kidney transplant recipients (KTRs) . Serum creatinine and proteinuria reflect kidney allograft function, but they are nonspecific tools. Despite its limitations (being invasive procedure with increased risk of bleeding and infection), kidney graft biopsy remains the gold standard method for confirming antibody-mediated rejection . Whilst kidney graft dysfunction could present with an elevated serum creatinine level, oliguria or pain over the graft site, it could also be asymptomatic. Imaging techniques plays an important role in the detection of anatomical as well as functional abnormalities in the early stages, thus allowing the chance for early treatment, as well as in the late post transplant period . Post-transplant complications can be divided into categories following the imaging-based classification of renal transplant complications: Perinephric collections, parenchymal abnormalities, abnormalities of the collecting system and vascular complications . The use of ultrasound to assess morphologic changes allows for the accurate and early detection of early pathologic alterations that may lead to rejection . Correlation of the ultrasound pattern with patient's history and clinical background is essential for a correct characterization. However, there are several limitations to ultrasound including its inability to assess renal function or differentiate between the different causes of renal dysfunction . Color Doppler ultrasonography, on the other hand, gives valuable information on the hemodynamics of the grafts' renal arteries. In the early post-transplant period, the resistive index(RI) measured in intrarenal arteries is thought to predict poor kidney graft performance . Doppler indices in different arteries differ in the detection of early parenchymal renal transplant complications. Resistive index of the interlobar artery proved to be more specific in the detection of early cases of parenchymal complications in a renal transplant patient . Color Doppler sonography had a limited value in the differentiation among the various etiologies of renal transplant dysfunction however the mean RI values were above normal in acute rejection and ATN . Vitamin D deficiency or vitamin D insufficiency is common and conflicting results concerning vitamin D deficiency -associated graft failure and mortality were described in kidney transplant recipients (KTRs). Many studies showed that Vitamin D deficiency , measured as 25-hydroxyvitamin D [25(OH)D] or 1,25-dihydroxyvitamin D [1,25(OH)2D], relates to kidney dysfunction in renal disease and graft loss in kidney transplant recipients . The association between low 1,25(OH)2D and graft failure was seen and was dependent on renal function. This association is not unexpected since the 1a-hydroxylase of the kidney, i.e., the enzyme that converts 25(OH)D into 1,25(OH)2D, is damaged simultaneously with the deterioration of renal function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All pediatric renal transplant recipients in their first year of transplantation.

Description

Inclusion Criteria:

  • All pediatric patients aged 1 to 18 years old
  • first renal transplant during the first year, pre and post complications.

Exclusion Criteria:

  • patients with recurrent renal transplantation.
  • Parental refusal to participate.
  • Patients with chronic rejection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
-Evaluation of pediatric renal patients during their first year after renal transplantation with doppler ultrasound by assessment of resistive index for early predictions of acute parenchymal rejection.
Time Frame: one year
one year
-Evaluation of pediatric renal patients during their first year after renal transplantation with doppler ultrasound for early detection of vascular complications.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Asmaa Ahmed, Lecturer, Assiut University
  • Study Director: Maher Mokhtar, Professor, Assiut University
  • Study Director: Ahlam badwy, A.Professor, Assiut University
  • Principal Investigator: Merna Ezzat, A. lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kidney transplantation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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