Transplant Recipient (Kidney)NCT01277770
Studies of Kidney Transplant Outcome
An observational study of Transplant Recipient (Kidney) and Steroid-Free Maintenance Immunosuppression, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to improve outcome for kidney transplant recipients. There has not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research is necessary to improve transplant outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplant Recipient (Kidney), Steroid-Free Maintenance Immunosuppression, Post-Transplant Infections
- What is being tested?
- Steroid-Free Maintenance Immunosuppression, Infection After Kidney Transplantation and Evaluation of the DGF nomogram in Thymoglobulin
- How many people
- 7,500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 6 May 2019
- 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: Kidney transplant recipients at the University of Minnesota
Who may be able to join
- Kidney Transplant Recipient at the University of Minnesota
- Kidney Transplant Recipients on steroid-free maintenance immunosuppression
Who cannot join
- Non-kidney transplant patients at the University of Minnesota
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Minnesota
Minneapolis, Minnesota, 55414
About this study
The purpose of this study is to improve outcome for kidney transplant recipients. There has not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research is necessary to improve transplant outcomes.
Read the detailed description
This study is looking at information already collected of transplant outcomes (short, medium and long-term complications and quality of life). This will specifically look at:
- 10 year follow-up of steroid-free maintenance immunosuppression
- A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients
- An evaluation of the Delayed Graft Function (DGF) nomogram in Thymoglobulin treated recipients at the University of Minnesota
- Conditions
- Transplant Recipient (Kidney), Steroid-Free Maintenance Immunosuppression, Post-Transplant Infections, Thymoglobulin
- Being tested
- Steroid-Free Maintenance Immunosuppression, Infection After Kidney Transplantation, Evaluation of the DGF nomogram in Thymoglobulin
- Keywords
- Thymoglobulin, Kidney Transplant Recipients, Steroid-Free, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid-Free Maintenance ImmunosuppressionDrug
Also called Steroid-Free, Immunosuppression
10 year follow-up of steroid-free maintenance immunosuppression
Infection After Kidney TransplantationOther
Also called Infection, Transplantation, Steroid-Free
A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients).
Evaluation of the DGF nomogram in ThymoglobulinDrug
Also called Thymoglobulin
An evaluation of the DGF nomogram in Thymoglobulin treated recipients at the University of Minnesota
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipients | Kidney Transplant Recipients at the University of Minnesota since 1984. The study looks at a 10 year followup of steroid-free maintenance immunosuppression, post-transplant infections and evaluation of the DGF nomogram in Thymoglobulin on patients at the University of Minnesota. Receives: Drug: Steroid-Free Maintenance Immunosuppression; Other: Infection After Kidney Transplantation; Drug: Evaluation of the DGF nomogram in Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Analysis
All studies are analyses from the Transplant Outcomes Database. Recipients have signed consent to have medical information entered into the database for these analyses. The database contains information on short, medium and long-term results.
Measured: 10 year followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startMay 2009
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Recipient (Kidney)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Arthur Matas, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277770
- Sponsor's protocol ID
- 00011652
- Status last verified
- May 2019
- First submitted
- 19 Aug 2010
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Kidney Transplant Outcome
- ClinicalTrials.gov ID
- NCT01277770
- Acronym / sponsor ID
- 00011652
- Conditions
- Transplant Recipient (Kidney), Steroid-Free Maintenance Immunosuppression, Post-Transplant Infections, Thymoglobulin
- Keywords
- Thymoglobulin, Kidney Transplant Recipients, Steroid-Free, Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2009
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 17 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 improve outcome for kidney transplant recipients. There has not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research is necessary to improve transplant outcomes.
Detailed description
This study is looking at information already collected of transplant outcomes (short, medium and long-term complications and quality of life). This will specifically look at:
- 10 year follow-up of steroid-free maintenance immunosuppression
- A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients
- An evaluation of the Delayed Graft Function (DGF) nomogram in Thymoglobulin treated recipients at the University of Minnesota
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Recipients | – | Drug: Steroid-Free Maintenance Immunosuppression, Other: Infection After Kidney Transplantation, Drug: Evaluation of the DGF nomogram in ThymoglobulinKidney Transplant Recipients at the University of Minnesota since 1984. The study looks at a 10 year followup of steroid-free maintenance immunosuppression, post-transplant infections and evaluation of the DGF nomogram in Thymoglobulin on patients at the University of Minnesota. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplant recipients at the University of Minnesota
Key inclusion criteria (2 listed)
- Kidney Transplant Recipient at the University of Minnesota
- Kidney Transplant Recipients on steroid-free maintenance immunosuppression
Key exclusion criteria (1 listed)
- Non-kidney transplant patients at the University of Minnesota
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 |
|---|---|---|
| Steroid-Free Maintenance ImmunosuppressionAlso: Steroid-Free, Immunosuppression10 year follow-up of steroid-free maintenance immunosuppression | Drug | Kidney Transplant Recipients |
| Infection After Kidney TransplantationAlso: Infection, Transplantation, Steroid-FreeA cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients). | Other | Kidney Transplant Recipients |
| Evaluation of the DGF nomogram in ThymoglobulinAlso: ThymoglobulinAn evaluation of the DGF nomogram in Thymoglobulin treated recipients at the University of Minnesota | Drug | Kidney Transplant Recipients |
Primary outcome
Data Analysis
Time frame: 10 year followup
All studies are analyses from the Transplant Outcomes Database. Recipients have signed consent to have medical information entered into the database for these analyses. The database contains information on short, medium and long-term results.
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 15 May 2019.
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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.
Arthur Matas, MD principal investigator
University of Minnesota
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 Transplant Recipient (Kidney) and Steroid-Free Maintenance Immunosuppression, run by University of Minnesota 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 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 15 May 2019. 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?
Data Analysis (time frame: 10 year followup). 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 15 May 2019.