Transplant; Failure, KidneyNCT01679184
XM-One Study for Living Donor Program
An observational study of Transplant; Failure, Kidney, run by University of Miami at 1 site in United States.
Trial summary
Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to living kidney transplantation and randomize these individuals into a desensitization protocol in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment and up to 6 months post transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplant; Failure, Kidney
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Living donor kidney transplant recipients
Who may be able to join
- Recipients receiving deceased donor transplants.
- Living donor transplant that is T-cell flow crossmatch positive.
- HIV, Hepatitis C and B positive patients.
Who cannot join
- Pregnant women and children will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to living kidney transplantation and randomize these individuals into a desensitization protocol in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment and up to 6 months post transplant.
If desensitization is needed prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.
Read the detailed description
- Rates of acute rejection including subclinical rejection - acute T cell mediated (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the groups.
- Evaluation of endothelial cell activation and injury on biopsies by checking markers for endothelial cell activation and injury (intercellular adhesion molecule-1, ICAM-1/CD54; vascular cell adhesion molecule-1, VCAM-1/CD106; and E-selectin, ELAM-1/CD62E) in two-color stains of tissue with classical endothelial markers (CD34 and Factor VIII).
- Measurement of serum/plasma levels of TNF-alpha and VEGF and decreased levels of protein C and protein S in the circulation, as an assessment of graft vascular perturbation.
- Circulating Endothelial Cells (CECs) will be measured by flow cytometry with markers for endothelial cell activation.
- Conditions
- Transplant; Failure, Kidney
What is being measured
The primary outcome is the main question the study is designed to answer.
DSA
To evaluate Donor-Specific Antibody (DSA) (HLA) levels with Luminex testing and non-HLA antibody levels using XM-One assay in recipients before and after transplantation for up to 6 months as well as in those recipients undergoing desensitization treatment.
Measured: 1 year
Secondary outcomes (1)
DSA
Rates of acute rejection including subclinical rejection - acute T cell mediated (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the groups.
Determine role of desensitization prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - based on Luminex and XM-One testing. Patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.
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 posted5 Sep 2012 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Lack of staff to enroll patients in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Failure, KidneyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Guerra, University of Miami
- Investigators
- Giselle Guerra, R.N., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679184
- Sponsor's protocol ID
- XM-One
- Status last verified
- Nov 2015
- First submitted
- 31 Aug 2012
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XM-One Study for Living Donor Program
- ClinicalTrials.gov ID
- NCT01679184
- Acronym / sponsor ID
- XM-One
- Conditions
- Transplant; Failure, Kidney
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of staff to enroll patients in this study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Sep 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.
Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to living kidney transplantation and randomize these individuals into a desensitization protocol in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment and up to 6 months post transplant.
If desensitization is needed prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.
Detailed description
- Rates of acute rejection including subclinical rejection - acute T cell mediated (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the groups.
- Evaluation of endothelial cell activation and injury on biopsies by checking markers for endothelial cell activation and injury (intercellular adhesion molecule-1, ICAM-1/CD54; vascular cell adhesion molecule-1, VCAM-1/CD106; and E-selectin, ELAM-1/CD62E) in two-color stains of tissue with classical endothelial markers (CD34 and Factor VIII).
- Measurement of serum/plasma levels of TNF-alpha and VEGF and decreased levels of protein C and protein S in the circulation, as an assessment of graft vascular perturbation.
- Circulating Endothelial Cells (CECs) will be measured by flow cytometry with markers for endothelial cell activation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Living donor kidney transplant recipients
Key inclusion criteria (3 listed)
- Recipients receiving deceased donor transplants.
- Living donor transplant that is T-cell flow crossmatch positive.
- HIV, Hepatitis C and B positive patients.
Key exclusion criteria (1 listed)
- Pregnant women and children will be excluded from the study.
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
DSA
Time frame: 1 year
To evaluate Donor-Specific Antibody (DSA) (HLA) levels with Luminex testing and non-HLA antibody levels using XM-One assay in recipients before and after transplantation for up to 6 months as well as in those recipients undergoing desensitization treatment.
1 secondary outcome
DSA
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of staff to enroll patients in this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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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.
Giselle Guerra, R.N. principal investigator
University of Miami
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; Failure, Kidney, run by University of Miami 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 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 13 Nov 2015. 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: Lack of staff to enroll patients in this study). 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?
DSA (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 13 Nov 2015; AzTrials last refreshed its copy on 27 Oct 2026.