Kidney TransplantationNCT01615341
Study of Subclinical Viral Infection
An observational study of Kidney Transplantation and Kidney Failure, Chronic, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Chronic allograft injury is the leading cause of graft loss in renal transplantation. The shortage of available kidneys for transplantation has reached crisis levels with increasing numbers of waiting list mortalities. Strategies to prolong graft survival are urgently needed. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Kidney Transplantation, Kidney Failure, Chronic
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2016
- 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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric and young adult renal transplant recipients (1<25yrs) of their first kidney transplant from Seattle Children's Hospital and University of Washington Medical Center.
Who may be able to join
- Subject and/or parent guardian must be able to understand and provide informed consent or assent
- Male or Female, Seattle Children's Hospital participants must be 1-<21 yrs and University of Washington Medical Center participants 18-25yrs.
- Diagnosed with End Stage Renal Disease (ESRD)
Who cannot join
- Inability or unwillingness of subject and/or parent guardian to provide informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Subclinical Viral Infection and Renal Allograft Injury
Chronic allograft injury is the leading cause of graft loss in renal transplantation. The shortage of available kidneys for transplantation has reached crisis levels with increasing numbers of waiting list mortalities. Strategies to prolong graft survival are urgently needed. The pediatric and young adult transplant population is one in which repeat transplantation is inevitable and therefore, this group is one who will especially benefit from intervention to prolong graft survival. The hypothesis of this proposal is that subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic allograft injury. The young age of the proposed study population is an ideal one to evaluate this objective due to the high prevalence of seronegative recipients. The studies outlined will determine the temporal relationship betWeween subclinical viremia, renal allograft infection and allograft injury. This will be the first prospective study in renal transplant recipients to systematically monitor subclinical viral infection both in peripheral blood and in the renal allograft with concurrent quantitative measures of renal function, allograft fibrosis, and innate immune activation. The investigators have chosen these 3 outcomes because they evaluate a spectrum of renal allograft injury and represent different stages - from early to late - in the pathophysiology that leads to renal allograft dysfunction. In addition, the role of virus specific T cell immune responses in the control of subclinical viral infection and associated allograft injury will be determined. These data are critical as they will provide insights into the pathogenesis of injury and will guide development of interventions strategies. Importantly, the current treatment strategies for viral disease do not prevent subclinical viral infection. Thus, the results of this study may identify that prevention, prophylaxis and/or treatment of subclinical viral replication as a long term strategy to prevent chronic allograft injury and prolong graft survival.
- Conditions
- Kidney Transplantation, Kidney Failure, Chronic
- Keywords
- Kidney transplantation, Subclinical Viral Infection, Renal Allograft Injury
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured GFR from baseline
Single infusion of iohexol clearance to measure GFR
Measured: time of transplant, one time between months 3 and 6, and during months 12, and 24 after the transplant
Secondary outcomes (2)
Change in interstitial fibrosis and tubular atrophy of renal allograft from baseline
Measured: Renal biopsies will be performed at time of transplant, 3-6 m, 12m, and 24m post-transplant. Precise measures of renal function, allograft fibrosis, and innate immune activation will be performed at baseline, 6m, 12, 24m post-transplant.
Change in innate immune activation of renal allograft from baseline
Measured: 6, 12, and 24 months after the transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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 Seattle Children's HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Jodi Smith, Seattle Children's Hospital
- Investigators
- Jodi Smith, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615341
- Sponsor's protocol ID
- R01DK088914-01A1
- Status last verified
- Jun 2012
- First submitted
- 6 Jun 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Viral Infection and Renal Allograft Injury
- ClinicalTrials.gov ID
- NCT01615341
- Acronym / sponsor ID
- R01DK088914-01A1
- Conditions
- Kidney Transplantation, Kidney Failure, Chronic
- Keywords
- Kidney transplantation, Subclinical Viral Infection, Renal Allograft Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Oct 2011
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 8 Jun 2012 (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.
Chronic allograft injury is the leading cause of graft loss in renal transplantation. The shortage of available kidneys for transplantation has reached crisis levels with increasing numbers of waiting list mortalities. Strategies to prolong graft survival are urgently needed. The pediatric and young adult transplant population is one in which repeat transplantation is inevitable and therefore, this group is one who will especially benefit from intervention to prolong graft survival. The hypothesis of this proposal is that subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic allograft injury. The young age of the proposed study population is an ideal one to evaluate this objective due to the high prevalence of seronegative recipients. The studies outlined will determine the temporal relationship betWeween subclinical viremia, renal allograft infection and allograft injury. This will be the first prospective study in renal transplant recipients to systematically monitor subclinical viral infection both in peripheral blood and in the renal allograft with concurrent quantitative measures of renal function, allograft fibrosis, and innate immune activation. The investigators have chosen these 3 outcomes because they evaluate a spectrum of renal allograft injury and represent different stages - from early to late - in the pathophysiology that leads to renal allograft dysfunction. In addition, the role of virus specific T cell immune responses in the control of subclinical viral infection and associated allograft injury will be determined. These data are critical as they will provide insights into the pathogenesis of injury and will guide development of interventions strategies. Importantly, the current treatment strategies for viral disease do not prevent subclinical viral infection. Thus, the results of this study may identify that prevention, prophylaxis and/or treatment of subclinical viral replication as a long term strategy to prevent chronic allograft injury and prolong graft survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric and young adult renal transplant recipients (1<25yrs) of their first kidney transplant from Seattle Children's Hospital and University of Washington Medical Center.
Key inclusion criteria (3 listed)
- Subject and/or parent guardian must be able to understand and provide informed consent or assent
- Male or Female, Seattle Children's Hospital participants must be 1-<21 yrs and University of Washington Medical Center participants 18-25yrs.
- Diagnosed with End Stage Renal Disease (ESRD)
Key exclusion criteria (2 listed)
- Inability or unwillingness of subject and/or parent guardian to provide informed consent
- Pregnancy
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 measured GFR from baseline
Time frame: time of transplant, one time between months 3 and 6, and during months 12, and 24 after the transplant
Single infusion of iohexol clearance to measure GFR
2 secondary outcomes
Change in interstitial fibrosis and tubular atrophy of renal allograft from baseline
Time frame: Renal biopsies will be performed at time of transplant, 3-6 m, 12m, and 24m post-transplant. Precise measures of renal function, allograft fibrosis, and innate immune activation will be performed at baseline, 6m, 12, 24m post-transplant.
Change in innate immune activation of renal allograft from baseline
Time frame: 6, 12, and 24 months after the transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
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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.
Jodi Smith, MD principal investigator
Seattle Children's Hospital
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 Kidney Failure, Chronic, run by Seattle Children's Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 8 Jun 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jodi Smith, MD (206-987-2524, jodi.smith@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measured GFR from baseline (time frame: time of transplant, one time between months 3 and 6, and during months 12, and 24 after the transplant). 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 8 Jun 2012.