Kidney TransplantNCT05298904
Pro-active Genetic Testing in Kidney Transplant Patients
An observational study of Kidney Transplant, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Genetic Health Screen Panel
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 1 Mar 2038
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified internally to Mayo Clinic Arizona via the kidney transplant program within one-year post transplant.
Who may be able to join
- Post transplant Kidney and Kidney Pancreas recipients.
Who cannot join
- Simultaneous Liver Kidney Transplant.
- Simultaneous Heart Kidney Transplant.
- Non renal transplant history.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer.
- Conditions
- Kidney Transplant
- Being tested
- Genetic Health Screen Panel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic Health Screen PanelDiagnostic test
This panel covers cardiomyopathy genes, and cancer genes. The results of this panel are reported as Positive (pathogenic or likely pathogenic mutation identified in one or more genes) or Negative (no pathogenic/likely pathogenic mutations identified).
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplants | Kidney transplant patients who are within one-year post transplant. Receives: Diagnostic Test: Genetic Health Screen Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic mutations of cancer
Number of subjects to have genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona
Measured: 1 year
Secondary outcomes (2)
The impact of genetic testing
Current guidelines for cancer screening have limitations, as its mostly age based. Immunosuppression can lead to a increased risk of cancer in the kidney transplant population.
By utilizing a multi gene panel we'll look for the number subjects with positive findings and see how recommendations of care change vs standard of care as recommended by the National Comprehensive Cancer Network (NCCN). Genetic testing and family history may change the practice regarding cancer screening in subjects undergoing kidney transplant evaluation.
Measured: 1 year
Develop a Biorepository
Create a biorepository based on whole exome sequencing and clinical data for future analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start28 Mar 2022
- Primary completion1 Mar 2037 (estimated)
- Study completion1 Mar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Girish K. Mour, Mayo Clinic
- Investigators
- Girish Mour, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298904
- Sponsor's protocol ID
- 21-009697
- Other IDs
- NCI-2022-02382
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2022
- Last updated
- 27 Jan 2026
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pro-active Genetic Testing in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT05298904
- Acronym / sponsor ID
- 21-009697
- Conditions
- Kidney Transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 1 Mar 2037 (estimated)
- Study completion
- 1 Mar 2038 (estimated)
- First posted
- 28 Mar 2022 (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.
The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplants | – | Diagnostic Test: Genetic Health Screen PanelKidney transplant patients who are within one-year post transplant. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified internally to Mayo Clinic Arizona via the kidney transplant program within one-year post transplant.
Key inclusion criteria (1 listed)
- Post transplant Kidney and Kidney Pancreas recipients.
Key exclusion criteria (3 listed)
- Simultaneous Liver Kidney Transplant.
- Simultaneous Heart Kidney Transplant.
- Non renal transplant history.
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 |
|---|---|---|
| Genetic Health Screen PanelThis panel covers cardiomyopathy genes, and cancer genes. The results of this panel are reported as Positive (pathogenic or likely pathogenic mutation identified in one or more genes) or Negative (no pathogenic/likely pathogenic mutations identified). | Diagnostic test | Kidney Transplants |
Primary outcome
Genetic mutations of cancer
Time frame: 1 year
Number of subjects to have genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona
2 secondary outcomes
The impact of genetic testing
Time frame: 1 year
Develop a Biorepository
Time frame: 1 year
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 27 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
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Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
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.
Girish Mour, MD principal investigator
Mayo Clinic
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 Kidney Transplant, run by Mayo Clinic at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. 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 United States. 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?
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?
Genetic mutations of cancer (time frame: 1 year). 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 27 Jan 2026.