Kidney DiseaseNCT01974999
A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study
An observational study of Kidney Disease and Kidney Failure, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 2 countries.
Trial summary
This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Disease, Kidney Failure, End Stage Renal Disease
- How many people
- 184 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2013to Jul 2014
- 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: The study population was selected based on their previous participation in the parent study (CTOT-01). A total of 280 subjects were enrolled and transplanted in the Clinical Trials in Organ Transplantation
Who may be able to join
- Participants previously enrolled in the CTOT-01 study.
- Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014.
Who cannot join
- Withdrawal of consent to continue in the CTOT-01 study.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Emory University
Atlanta, Georgia, 30322
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic Foundation, Glickman Urological Institute
Cleveland, Ohio, 44195
Yale University School of Medicine
New Haven, Connecticut, 06510
Mount Sinai School of Medicine
New York, New York, 10029
Canada2 sites
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Children's Hospital of Winnipeg
Winnipeg, Manitoba
About this study
Official title: A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)
This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.
- Conditions
- Kidney Disease, Kidney Failure, End Stage Renal Disease
- Keywords
- Kidney, Transplant, Rejection
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Kidney Failure, Chronic, Rejection, Psychology
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation
Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort
Measured: Day 1
Secondary outcomes (4)
Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant
Measured: Day 1
Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant
Measured: Day 1
Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant
Measured: Day 1
Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation
- Responsible party
- Sponsor
- Investigators
- Peter S Heeger, MD, Principal investigator, Icahn School of Medicine at Mount SinaiDonald E Hricik, MD, Study chair, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974999
- Sponsor's protocol ID
- DAIT CTOT-17
- Status last verified
- Sep 2026
- First submitted
- 28 Oct 2013
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Faddoul G, Nadkarni GN, Bridges ND, Goebel J, Hricik DE, Formica R, Menon MC, Morrison Y, Murphy B, Newell K, Nickerson P, Poggio ED, Rush D, Heeger PS; CTOT-17 consortium. Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes: Results From Clinical Trials in Organ Transplantation-17. Transplantation. 2018 Apr;102(4):673-680. doi: 10.1097/TP.0000000000002026.
PubMed 29189482
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
- A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)
- ClinicalTrials.gov ID
- NCT01974999
- Acronym / sponsor ID
- DAIT CTOT-17
- Conditions
- Kidney Disease, Kidney Failure, End Stage Renal Disease
- Keywords
- Kidney, Transplant, Rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Nov 2013 (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.
This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was selected based on their previous participation in the parent study (CTOT-01). A total of 280 subjects were enrolled and transplanted in the Clinical Trials in Organ Transplantation
Key inclusion criteria (2 listed)
- Participants previously enrolled in the CTOT-01 study.
- Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014.
Key exclusion criteria (1 listed)
- Withdrawal of consent to continue in the CTOT-01 study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation
Time frame: Day 1
Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort
4 secondary outcomes
Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant
Time frame: Day 1
Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant
Time frame: Day 1
Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant
Time frame: Day 1
Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant
Time frame: Day 1
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.
- Results publication: PubMed 29189482Faddoul G, Nadkarni GN, Bridges ND, Goebel J, Hricik DE, Formica R, Menon MC, Morrison Y, Murphy B, Newell K, Nickerson P, Poggio ED, Rush D, Heeger PS; CTOT-17 consortium. Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes: Results From Clinical Trials in Organ Transplantation-17. Transplantation. 2018 Apr;102(4):673-680. doi: 10.1097/TP.0000000000002026.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
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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 principal investigator
Icahn School of Medicine at Mount Sinai
Donald E Hricik, MD study chair
University Hospitals Cleveland Medical Center
7 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 Disease and Kidney Failure, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 2 inclusion and 1 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 7 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.
What does the primary outcome measure?
Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974999, which also lists 1 linked publication.
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.