Kidney TransplantationNCT00308802
Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients
An observational study of Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.
Trial summary
The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Kidney transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Mar 2006to Jul 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People who are candidates for kidney transplant
Who may be able to join
- Candidate for deceased donor or living donor kidney transplant
- Negative Crossmatch
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- Clinically significant liver disease
- Other illnesses that, in the opinion of the investigator, may interfere with the study
- Recipient of multiple organ transplants
- Inability or unwillingness to comply with the study protocol
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Emory Children's Center
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University Hospitals of Cleveland
Cleveland, Ohio, 44195
Yale University School of Medicine
New Haven, Connecticut, 06510
Mount Sinai School of Medicine
New York, New York, 10029
Canada2 sites
Children's Hospital of Winnipeg
Winnipeg, Manitoba, R3A 151
University of Manitoba
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients
The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants.
Read the detailed description
Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys.
This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.
- Conditions
- Kidney Transplantation
- Being tested
- Kidney transplantation
- Keywords
- Kidney, Transplant, Rejection, Kidney Disease, Kidney Failure, End Stage Renal Disease
- Medical subject headings
- Rejection, Psychology, Kidney Diseases, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney transplantationProcedure or surgery
Participants in this study will have had a kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter S. Heeger, MD, Study director, Icahn School of Medicine at Mount SinaiDonald Hricik, MD, Principal investigator, University Hospitals Cleveland Medical CenterDavid Rush, MD, Principal investigator, University of Manitoba at WinnipegKenneth Newell, MD, Principal investigator, Emory UniversityRichard Formica, MD, Principal investigator, Yale UniversityEmilio Poggio, MD, Principal investigator, The Cleveland ClinicBarry Warshaw, MD, Principal investigator, Emory-Children's CenterEnver Akalin, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308802
- Sponsor's protocol ID
- DAIT CTOT-01
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2006
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaplan B, Srinivas TR, Meier-Kriesche HU. Factors associated with long-term renal allograft survival. Ther Drug Monit. 2002 Feb;24(1):36-9. doi: 10.1097/00007691-200202000-00007.
PubMed 11805720Meier-Kriesche HU, Schold JD, Kaplan B. Long-term renal allograft survival: have we made significant progress or is it time to rethink our analytic and therapeutic strategies? Am J Transplant. 2004 Aug;4(8):1289-95. doi: 10.1111/j.1600-6143.2004.00515.x.
PubMed 15268730Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
PubMed 14961990Hricik DE, Nickerson P, Formica RN, Poggio ED, Rush D, Newell KA, Goebel J, Gibson IW, Fairchild RL, Riggs M, Spain K, Ikle D, Bridges ND, Heeger PS; CTOT-01 consortium. Multicenter validation of urinary CXCL9 as a risk-stratifying biomarker for kidney transplant injury. Am J Transplant. 2013 Oct;13(10):2634-44. doi: 10.1111/ajt.12426. Epub 2013 Aug 22.
PubMed 23968332
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00308802
- Acronym / sponsor ID
- DAIT CTOT-01
- Conditions
- Kidney Transplantation
- Keywords
- Kidney, Transplant, Rejection, Kidney Disease, Kidney Failure, End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Mar 2006 (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 test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants.
Detailed description
Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys.
This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who are candidates for kidney transplant
Key inclusion criteria (3 listed)
- Candidate for deceased donor or living donor kidney transplant
- Negative Crossmatch
- Parent or guardian willing to provide informed consent, if applicable
Key exclusion criteria (4 listed)
- Clinically significant liver disease
- Other illnesses that, in the opinion of the investigator, may interfere with the study
- Recipient of multiple organ transplants
- Inability or unwillingness to comply with the study protocol
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 transplantationParticipants in this study will have had a kidney transplant | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 25 Sep 2026.
- Background: PubMed 11805720Kaplan B, Srinivas TR, Meier-Kriesche HU. Factors associated with long-term renal allograft survival. Ther Drug Monit. 2002 Feb;24(1):36-9. doi: 10.1097/00007691-200202000-00007.
- Background: PubMed 15268730Meier-Kriesche HU, Schold JD, Kaplan B. Long-term renal allograft survival: have we made significant progress or is it time to rethink our analytic and therapeutic strategies? Am J Transplant. 2004 Aug;4(8):1289-95. doi: 10.1111/j.1600-6143.2004.00515.x.
- Background: PubMed 14961990Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
- Results publication: PubMed 23968332Hricik DE, Nickerson P, Formica RN, Poggio ED, Rush D, Newell KA, Goebel J, Gibson IW, Fairchild RL, Riggs M, Spain K, Ikle D, Bridges ND, Heeger PS; CTOT-01 consortium. Multicenter validation of urinary CXCL9 as a risk-stratifying biomarker for kidney transplant injury. Am J Transplant. 2013 Oct;13(10):2634-44. doi: 10.1111/ajt.12426. Epub 2013 Aug 22.
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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.
Peter S. Heeger, MD study director
Icahn School of Medicine at Mount Sinai
Donald Hricik, MD principal investigator
University Hospitals Cleveland Medical Center
David Rush, MD principal investigator
University of Manitoba at Winnipeg
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.
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 3 inclusion and 4 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308802, which also lists 4 linked publications.
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 25 Sep 2026.