GEnomic Medicine in Kidney Transplantation Study (GEM-KiT)

March 24, 2025 updated by: Jennifer Li, Western Sydney Local Health District

Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.

  1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
  2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
  3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
1000

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.

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult, kidney transplant (or kidney-pancreas transplant) recipients

Description

Inclusion Criteria: All participants included in the study must be age ≥ 18 years old at time of enrolment and

  1. able to provide informed consent (interpreter permitted) for enrolment
  2. consenting to longitudinal follow up (can withdraw post enrolment)
  3. consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)

Exclusion Criteria: Patients will be excluded from the study if they are

  1. unable (or unwilling) to provide consent, or
  2. have life-expectancy less than 6-months, or
  3. have received a haematopoietic stem cell transplant in the past 5 years.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Kidney Transplant Recipients
Enrolled at time of transplant or post transplant
Diagnostic test: Biomarker discovery and validation - with focus on genomic biomarkers
Biomarker discovery and validation - with focus on genomic biomarkers

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
Measure Description
Time Frame
Death censored graft loss (DCGL)
Time Frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
Loss of functioning kidney transplant (not counted if patient died with functioning graft)
At biopsy or during study follow up after biopsy (expected average over 60-months)
Biopsy proven rejection (BPAR)
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Rejection diagnosed on kidney transplant biopsy
At biopsy or during study follow up after biopsy (expected average 12-months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kidney biopsy transcriptomic signature
Time Frame: At biopsy - based on collected tissue sample
Based on bulk and/or spatial transcriptomic experiments
At biopsy - based on collected tissue sample
Kidney cell type composition
Time Frame: At biopsy - based on collected tissue sample
Cell type phenotyping of immune and kidney cell types
At biopsy - based on collected tissue sample
Treatment resistant rejection
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression
At biopsy or during study follow up after biopsy (expected average 12-months)
All cause graft loss
Time Frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
DCGL or death with functioning graft
At biopsy or during study follow up after biopsy (expected average over 60-months)
Death
Time Frame: Any time during or after biopsy (expected over 60-months)
Death
Any time during or after biopsy (expected over 60-months)
Hospital admission or emergency attendance
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Hospital admission or emergency department visit for any reason
At biopsy or during study follow up after biopsy (expected average 12-months)
Delayed Graft Function (DGF)
Time Frame: within the first 7 days post transplantation
Need for dialysis within the first 7 days post transplantation
within the first 7 days post transplantation
Kidney function
Time Frame: Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation
serum creatinine and eGFR post transplantation
Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation
Albuminuria
Time Frame: Months 1, 3, 12 any time after 12-months trnasplantation
albumin in the urine (UACR)
Months 1, 3, 12 any time after 12-months trnasplantation
Surrogate end-point markers
Time Frame: Months 3, 12, 24, 36, 48 and 60, 120 post transplantation
eGFR slope and iBOX scores
Months 3, 12, 24, 36, 48 and 60, 120 post transplantation
Borderline rejeciton
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Based on banff scoring criteria for kidney biospies
At biopsy or during study follow up after biopsy (expected average 12-months)
chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores
Time Frame: At biopsy or during study follow up after biopsy (expected average over 12-months)
Based on banff scoring for kidney biopsies
At biopsy or during study follow up after biopsy (expected average over 12-months)
Recurrent disease
Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
recurrence of original disease causing kidney failure
At biopsy or during study follow up after biopsy (expected average 60-months)
BK virus complications
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Viremia or virus associated nephropathy
At biopsy or during study follow up after biopsy (expected average 12-months)
Major cardiovascular complications
Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
3-point MACE: non fatal stroke, non fatal myocardial infarction, cardiovascular death
At biopsy or during study follow up after biopsy (expected average 60-months)
Major infectious complications
Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
any major fungal, bacterial or viral infection
At biopsy or during study follow up after biopsy (expected average 60-months)
Malignancy post transplantation
Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
any cancer type
At biopsy or during study follow up after biopsy (expected average 60-months)
Proteinomic signature
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
mass spectrometry or spatial proteinomic results
At biopsy or during study follow up after biopsy (expected average 12-months)

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.
Western Sydney Local Health District

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.
June 3, 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.
January 1, 2030

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.
January 1, 2035

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).
March 10, 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.
April 9, 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.
April 15, 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.
March 28, 2025

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.
March 24, 2025

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.
April 1, 2024

More Information

Terms related to this study

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.
  • GEM-KiT

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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