Kidney TransplantationNCT00585858
Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant
An observational study of Kidney Transplantation and Liver Transplantation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if there is clinical correlation between the CKT and transplant recipients who are known to be on minimal or no immunosuppression (presumed tolerant) and those who are on conventional amounts of immunosuppression and have either experienced rejection (presumed… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Liver Transplantation
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2008
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Kidney or liver transplant recipients
Who may be able to join
- Kidney or liver transplant recipients for whom donor cells are available
Who cannot join
- HcT <32%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytokine Kinetics Assay to Assess the Presence or Absence of Tolerance in Organ Transplant Recipients
The purpose of this pilot study is to determine if there is clinical correlation between the CKT and transplant recipients who are known to be on minimal or no immunosuppression (presumed tolerant) and those who are on conventional amounts of immunosuppression and have either experienced rejection (presumed hyper-responsive to donor) or have not experienced rejection (unknown responsive state).
- Conditions
- Kidney Transplantation, Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects on mimimal or no immunosuppression and no rejection history | |
| 2 | Subjects who have had rejection on conventional immunosuppression | |
| 3 | Subjects who have not had acute or chronic rejection who are on conventional immunosuppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between cytokine kinetics test and clinical status of subject
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 posted3 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: PI leaving institution
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 University of Wisconsin, MadisonThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585858
- Sponsor's protocol ID
- H-2006-0437
- Status last verified
- May 2016
- First submitted
- 26 Dec 2007
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Kinetics Assay to Assess the Presence or Absence of Tolerance in Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT00585858
- Acronym / sponsor ID
- H-2006-0437
- Conditions
- Kidney Transplantation, Liver Transplantation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Jan 2008 (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 pilot study is to determine if there is clinical correlation between the CKT and transplant recipients who are known to be on minimal or no immunosuppression (presumed tolerant) and those who are on conventional amounts of immunosuppression and have either experienced rejection (presumed hyper-responsive to donor) or have not experienced rejection (unknown responsive state).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects on mimimal or no immunosuppression and no rejection history |
| 2 | – | –Subjects who have had rejection on conventional immunosuppression |
| 3 | – | –Subjects who have not had acute or chronic rejection who are on conventional immunosuppression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney or liver transplant recipients
Key inclusion criteria (1 listed)
- Kidney or liver transplant recipients for whom donor cells are available
Key exclusion criteria (1 listed)
- HcT <32%
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
Correlation between cytokine kinetics test and clinical status of subject
Time frame: 1 year
Results and safety
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Liver Transplantation, run by University of Wisconsin, Madison 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 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: stopped early, as of the sponsor's last update on 12 May 2016. 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 was stopped early (reason given: PI leaving institution). Results are not available in the source record.
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?
Correlation between cytokine kinetics test and clinical status of subject (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 12 May 2016.