Kidney FailurePRISMNCT03794817
Immune Monitoring in Sensitized Patients at Risk of Rejection
An observational study of Kidney Failure, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of anti-rejection medications on your immune system Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Failure
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2015to 8 Sep 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received a kidney transplant and will be taking immunosuppressive medications.
Who may be able to join
- 18 years or older able to consent
- No history of HIV, hepatitis C and active hepatitis B infection
- cPRA ≥ 50%
Who cannot join
- Patients on Coumadin
- Human Leukocyte antigen (HLA) identical donor recipient patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
The purpose of this study is to test the effect of anti-rejection medications on your immune system
Read the detailed description
Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.
- Conditions
- Kidney Failure
- Keywords
- Kidney transplant recipient
- Medical subject headings
- Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune monitoring in sensitized patients at risk of rejection
Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation
Measured: 2 years
Secondary outcomes (1)
Kidney Solid Organ Response Test (kSORT) with pathological findings
Correlation of kSORT with pathological findings on kidney biopsy
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 posted7 Jan 2019
- Study start20 Aug 2015
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flavio Vincenti, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794817
- Sponsor's protocol ID
- PRISM
- Acronym
- PRISM
- Status last verified
- Jan 2019
- First submitted
- 12 Dec 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Monitoring in Sensitized Patients at Risk of Rejection
- ClinicalTrials.gov ID
- NCT03794817
- Acronym / sponsor ID
- PRISM / PRISM
- Conditions
- Kidney Failure
- Keywords
- Kidney transplant recipient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 7 Jan 2019 (actual)
- 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 test the effect of anti-rejection medications on your immune system
Detailed description
Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received a kidney transplant and will be taking immunosuppressive medications.
Key inclusion criteria (3 listed)
- 18 years or older able to consent
- No history of HIV, hepatitis C and active hepatitis B infection
- cPRA ≥ 50%
Key exclusion criteria (2 listed)
- Patients on Coumadin
- Human Leukocyte antigen (HLA) identical donor recipient patients
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
Immune monitoring in sensitized patients at risk of rejection
Time frame: 2 years
Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation
1 secondary outcome
Kidney Solid Organ Response Test (kSORT) with pathological findings
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 7 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Flavio Vincenti, M.D. principal investigator
University of California, San Francisco
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 Failure, run by University of California, San Francisco 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: finished, as of the sponsor's last update on 7 Jan 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?
Immune monitoring in sensitized patients at risk of rejection (time frame: 2 years). 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 7 Jan 2019.