Kidney TransplantationPIP-01NCT00788021
Protective Immunity Project 01
An observational study of Kidney Transplantation and Immunity, run by Emory University at 1 site in United States.
Trial summary
Patients who undergo kidney transplant must take medications to prevent organ rejection. There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf), mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent rejection. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Immunity, Immunosuppression
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Oct 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing deceased or living donor renal transplant
Who may be able to join
- Male or female patients between 18 and 59 years of age
- Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding.
Who cannot join
- Patients with any prior organ transplant or multi-organ transplant recipients
- Patients that require induction immunosuppression beyond the immunosuppressive regimen proposed in this study. For example, patients that receive anti-lymphocyte antibody therapy or plasmapheresis as a result of pre-formed immunologic reactivity to the transplanted organ.
- Patients with evidence of an active systemic infection requiring the continued use of antibiotics, evidence of an HIV infection, or the presence of a chronic active hepatitis B or C.
- Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
- Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 3000/mm3). -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Impact of Chronic Immunosuppressive Regimens on Protective Immunity Over Time in Renal Transplant Recipients
Patients who undergo kidney transplant must take medications to prevent organ rejection. There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf), mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent rejection. It is well known that patients on immunosuppressant medications are at increased risk from viral infections, such as influenza. However, it is not well understood how immunosuppressive medications may uniquely affect the immune response to infection. This study will determine whether there are unique differences in the effects on the immune system by these different immunosuppressive medications, particularly differences between tacrolimus and sirolimus.
Read the detailed description
While the benefits of transplantation to society are substantial, the ever-growing population of immunosuppressed recipients poses a unique challenge in development of immunization and containment strategies to protect the population from communicable pathogens and weaponized infectious agents. The immunosuppressive regimens that have allowed the emergence of successful transplant therapy not only inhibit T cell-dependent rejection but also cause systemic immunosuppression, which attenuates the response to vaccines in general and precludes the use of live attenuated vaccines. To date, there has been relatively little detailed systematic study of the immune alterations that accompany either the short- or long-term immunosuppressive regimens used in clinical organ transplantation. Despite the recent development of increasingly effective, but also increasingly complex, regimens using drugs with very distinct molecular targets, current policies on vaccination of transplant recipients are generic and remain based on old concepts rather than on any new understanding of the cellular and molecular effects of these therapies on the human immune system. This proposal seeks to improve our understanding of the biological mechanisms that underlie the distinct immunosuppressive regimens in practice today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) and in emerging regimens that employ agents with novel mechanisms of action, such as the CD28 costimulation blockers, and/or JAK3 kinase inhibitors. Such knowledge will be critical to strategies for enhancing desirable immune responses while not precipitating rejection.
- Conditions
- Kidney Transplantation, Immunity, Immunosuppression
- Keywords
- Transplant, Immunity, Immunosuppression
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 |
|---|---|---|
| Tacrolimus | Recipients of deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus | |
| Sirolimus | Recipients of deceased or living donor renal transplants maintained on immunosuppressive regimen using sirolimus | |
| Healthy controls | Age, race and gender-matched individuals not on immunosuppressive regimens. Whenever possible an transplant recipient's donor may be recruited to serve as healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of chronic immunosuppressive therapies on adaptive immunity
Measured: 2 years
To determine the effects of chronic immunosuppressive therapies on innate immunity, dendritic cell phenotype and function and TLR signaling
Measured: 2 years
To define the transcriptional signatures associated with specific immunosuppressive regimens
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startSep 2006
- Primary completionJan 2011
- Study completionOct 2011
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 Emory 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian P Larsen, MD, PhD, Emory University
- Investigators
- Christian P. Larsen, MD, DPhil, Principal investigator, Emory UniversityKenneth E. Kokko, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788021
- Sponsor's protocol ID
- IRB00000709
- Other IDs
- PIP-01
- Acronym
- PIP-01
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2008
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Impact of Chronic Immunosuppressive Regimens on Protective Immunity Over Time in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00788021
- Acronym / sponsor ID
- PIP-01 / IRB00000709
- Conditions
- Kidney Transplantation, Immunity, Immunosuppression
- Keywords
- Transplant, Immunity, Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Nov 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.
Patients who undergo kidney transplant must take medications to prevent organ rejection. There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf), mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent rejection. It is well known that patients on immunosuppressant medications are at increased risk from viral infections, such as influenza. However, it is not well understood how immunosuppressive medications may uniquely affect the immune response to infection. This study will determine whether there are unique differences in the effects on the immune system by these different immunosuppressive medications, particularly differences between tacrolimus and sirolimus.
Detailed description
While the benefits of transplantation to society are substantial, the ever-growing population of immunosuppressed recipients poses a unique challenge in development of immunization and containment strategies to protect the population from communicable pathogens and weaponized infectious agents. The immunosuppressive regimens that have allowed the emergence of successful transplant therapy not only inhibit T cell-dependent rejection but also cause systemic immunosuppression, which attenuates the response to vaccines in general and precludes the use of live attenuated vaccines. To date, there has been relatively little detailed systematic study of the immune alterations that accompany either the short- or long-term immunosuppressive regimens used in clinical organ transplantation. Despite the recent development of increasingly effective, but also increasingly complex, regimens using drugs with very distinct molecular targets, current policies on vaccination of transplant recipients are generic and remain based on old concepts rather than on any new understanding of the cellular and molecular effects of these therapies on the human immune system. This proposal seeks to improve our understanding of the biological mechanisms that underlie the distinct immunosuppressive regimens in practice today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) and in emerging regimens that employ agents with novel mechanisms of action, such as the CD28 costimulation blockers, and/or JAK3 kinase inhibitors. Such knowledge will be critical to strategies for enhancing desirable immune responses while not precipitating rejection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | – | –Recipients of deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus |
| Sirolimus | – | –Recipients of deceased or living donor renal transplants maintained on immunosuppressive regimen using sirolimus |
| Healthy controls | – | –Age, race and gender-matched individuals not on immunosuppressive regimens. Whenever possible an transplant recipient's donor may be recruited to serve as healthy control |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing deceased or living donor renal transplant
Key inclusion criteria (3 listed)
- Male or female patients between 18 and 59 years of age
- Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding.
Key exclusion criteria (5 listed)
- Patients with any prior organ transplant or multi-organ transplant recipients
- Patients that require induction immunosuppression beyond the immunosuppressive regimen proposed in this study. For example, patients that receive anti-lymphocyte antibody therapy or plasmapheresis as a result of pre-formed immunologic reactivity to the transplanted organ.
- Patients with evidence of an active systemic infection requiring the continued use of antibiotics, evidence of an HIV infection, or the presence of a chronic active hepatitis B or C.
- Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
- Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 3000/mm3). -
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
To determine the effects of chronic immunosuppressive therapies on adaptive immunity
Time frame: 2 years
To determine the effects of chronic immunosuppressive therapies on innate immunity, dendritic cell phenotype and function and TLR signaling
Time frame: 2 years
To define the transcriptional signatures associated with specific immunosuppressive regimens
Time frame: 2 years
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 Nov 2013.
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Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
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Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
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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.
Christian P. Larsen, MD, DPhil principal investigator
Emory University
Kenneth E. Kokko, MD, PhD principal investigator
Emory University
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 Immunity, run by Emory 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 3 inclusion and 5 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 Nov 2013. 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?
To determine the effects of chronic immunosuppressive therapies on adaptive immunity (time frame: 2 years). The study lists 3 primary outcomes in all. 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 25 Nov 2013.