Kidney TransplantationNCT01271465
Analysis of Donor Biopsy Tissue Samples at the Time of Kidney Transplant
An observational study of Kidney Transplantation, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to see if substances measured in a small piece of the donor organ predicts how well the organ will function in the recipient after transplant. We will be testing blood, urine, and biopsy tissue samples in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Kidney Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 18 Sep 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal allograft recipients are generally in good health and many return to work by three months post-transplant. However, they are maintained on immunosuppressive medications to maintain the function of the transplanted kidney.
Who may be able to join
- Males and females <80 years of age for kidney
- Recipients of single abdominal organ transplant
- Ability to provide written informed consent
- Donor blood and kidney biopsy tissues specimens are collected at the time of transplantation
Who cannot join
- Need for combined organ transplantation.
- Inability or unwillingness of a participant or legal guardian to provide written informed consent
- Clinical evidence of systemic bacterial infection in the recipient at the time of transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: mRNA and microRNA Profiles in Renal Transplant at the Time of Organ Reperfusion
The purpose of this study is to see if substances measured in a small piece of the donor organ predicts how well the organ will function in the recipient after transplant. We will be testing blood, urine, and biopsy tissue samples in this study. The research team will be looking at different risk factors in the donor organ that predict how well the kidney will do in the recipient.
Read the detailed description
Background:
Early post-transplant kidney function can be attributed to inherent donor characteristics, damage from storage, and perioperative events and recipients factors. The incidence of severe injury to the transplant kidneys is 10-25% in the early post-transplant period. In addition, milder forms of early transplant kidney injury can impact on long term allograft function. Severe transplant kidney injury in the immediate post-transplant period has been hypothesized to be associated with higher rates of rejection.
Hypothesis:
In the current investigation, we would like to test the hypotheses that 1) mRNA and microRNA expression of proinflammatory genes in donor tissues is a risk factor for development of early kidney transplant dysfunction and 2) early inflammatory mRNA and microRNA expression in the allograft is associated with subsequent activation of cell mediated immunity as evidenced by increased incidence of acute rejection episodes and increased expression of cell mediated immunity genes during the first year post-transplant.
Aims:
Aim 1: Test the association between proinflammatory mRNA and microRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation.
Aim 2: Test the association of mRNA and microRNA expression of proinflammatory mediators in the transplanted organ in the immediate pre and post-reperfusion period with subsequent incidence of acute rejection and expression of genes involved in cell mediated immunity.
- Conditions
- Kidney Transplantation
- Being tested
- Kidney Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney BiopsyProcedure or surgery
biopsy of transplant kidney
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early organ dysfunction, defined by standard criteria for each organ defined as the need for dialysis within 7 days after transplant and incidence of biopsy proven acute cellular rejection within 12 months of transplant
Measured: 7 days and 12 months, respectively
Secondary outcomes (2)
Serum Creatinine
Correlation between proinflammatory mediators at the time of transplantation and renal function as measured by serum creatinine
Measured: 24 months
Incidence of chronic allograft nephropathy
Correlation between proinflammatory mediators at the time of transplantation and incidence of chronic allograft nephropathy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startSep 2010
- Primary completion18 Sep 2021
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Qatar National Research Fund
- Responsible party
- Sponsor
- Investigators
- Samuel Sultan, MD, Principal investigator, Weill Cornell Medicine/Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271465
- Sponsor's protocol ID
- 1004010988
- Status last verified
- Nov 2025
- First submitted
- 5 Jan 2011
- Last updated
- 26 Nov 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mRNA and microRNA Profiles in Renal Transplant at the Time of Organ Reperfusion
- ClinicalTrials.gov ID
- NCT01271465
- Acronym / sponsor ID
- 1004010988
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Qatar National Research Fund
- Study start
- Sep 2010 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 6 Jan 2011 (estimated)
- 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 see if substances measured in a small piece of the donor organ predicts how well the organ will function in the recipient after transplant. We will be testing blood, urine, and biopsy tissue samples in this study. The research team will be looking at different risk factors in the donor organ that predict how well the kidney will do in the recipient.
Detailed description
Background:
Early post-transplant kidney function can be attributed to inherent donor characteristics, damage from storage, and perioperative events and recipients factors. The incidence of severe injury to the transplant kidneys is 10-25% in the early post-transplant period. In addition, milder forms of early transplant kidney injury can impact on long term allograft function. Severe transplant kidney injury in the immediate post-transplant period has been hypothesized to be associated with higher rates of rejection.
Hypothesis:
In the current investigation, we would like to test the hypotheses that 1) mRNA and microRNA expression of proinflammatory genes in donor tissues is a risk factor for development of early kidney transplant dysfunction and 2) early inflammatory mRNA and microRNA expression in the allograft is associated with subsequent activation of cell mediated immunity as evidenced by increased incidence of acute rejection episodes and increased expression of cell mediated immunity genes during the first year post-transplant.
Aims:
Aim 1: Test the association between proinflammatory mRNA and microRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation.
Aim 2: Test the association of mRNA and microRNA expression of proinflammatory mediators in the transplanted organ in the immediate pre and post-reperfusion period with subsequent incidence of acute rejection and expression of genes involved in cell mediated immunity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal allograft recipients are generally in good health and many return to work by three months post-transplant. However, they are maintained on immunosuppressive medications to maintain the function of the transplanted kidney.
Key inclusion criteria (4 listed)
- Males and females <80 years of age for kidney
- Recipients of single abdominal organ transplant
- Ability to provide written informed consent
- Donor blood and kidney biopsy tissues specimens are collected at the time of transplantation
Key exclusion criteria (3 listed)
- Need for combined organ transplantation.
- Inability or unwillingness of a participant or legal guardian to provide written informed consent
- Clinical evidence of systemic bacterial infection in the recipient at the time of transplantation
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 |
|---|---|---|
| Kidney Biopsybiopsy of transplant kidney | Procedure or surgery | – |
Primary outcome
Incidence of early organ dysfunction, defined by standard criteria for each organ defined as the need for dialysis within 7 days after transplant and incidence of biopsy proven acute cellular rejection within 12 months of transplant
Time frame: 7 days and 12 months, respectively
2 secondary outcomes
Serum Creatinine
Time frame: 24 months
Incidence of chronic allograft nephropathy
Time frame: 24 months
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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplantation
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Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
Samuel Sultan, MD principal investigator
Weill Cornell Medicine/Department of Surgery
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 Transplantation, run by Weill Medical College of Cornell University 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 4 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: finished, as of the sponsor's last update on 26 Nov 2025. 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?
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?
Incidence of early organ dysfunction, defined by standard criteria for each organ defined as the need for dialysis within 7 days after transplant and incidence of biopsy proven acute cellular rejection within 12 months of transplant (time frame: 7 days and 12 months, respectively). 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 26 Nov 2025.