Type 1 DiabetesNCT00867386
Desensitization for Highly Sensitized Recipients of Pancreas Transplantation
An observational study of Type 1 Diabetes and Rejection of Pancreas Transplant, run by Northwestern University at 1 site in United States.
Trial summary
This is an observational study for patients with type 1 diabetes, whom are already scheduled to have desensitization treatment to help increase the chance of receiving a pancreas transplant.The study staff will be looking at medical records in order to collect past, present and future information for each subject's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Rejection of Pancreas Transplant, Desensitization
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Oct 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of type 1 diabetes who are highly sensitized (defined as having panel reactive antibody (PRA) level >50%) who underwent successful desensitization treatment followed by a deceased donor pancreas transplantation at NMH .
Who may be able to join
- Pancreas transplant recipients with elevated panel reactive antibody levels of >50% and who have received desensitization treatment and subsequently receive their transplantation at Northwestern Memorial Hospital (NMH).
Who cannot join
- No Exclusion criteria exist.
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study for patients with type 1 diabetes, whom are already scheduled to have desensitization treatment to help increase the chance of receiving a pancreas transplant.The study staff will be looking at medical records in order to collect past, present and future information for each subject's medical condition and/or transplant. There are no additional study tests, procedures or devices needed for our analysis.
Read the detailed description
Please note that this study is observational. The treatment of each patient will be at the discretion of the care physician. The study investigators will ONLY be performing data collection and analysis.
Post transplant all patients will receive one additional cycle of plasma exchange with a moderate dose of Intravenous Immunoglobulin (IVIg) (0.4 mg/Kg). Antibody titers will be monitoring prior to plasma exchange and immediately following the treatment. At this point, since donor antigens are known, only antibodies to these antigens will be tested to minimize cost. We anticipate that in some patients, especially if the original titer of donor-specific antibody (DSA) was high (> 1:128), a rise in DSA will be observed following transplant. If indeed DSA will be present, additional monitoring will be initiated and the patient will be treated further with plasma exchange/IVIg cycles, with antibody monitoring before and immediately after each cycle. If no DSA are detected, patients will be monitoring on a every other day schedule for the first week; weekly for the next 3 weeks and monthly up to 6 months post transplant. Additional testing will be performed in the event of any clinical evidence of graft dysfunction, or following sever infection events.
Patient will be followed to 12 month post transplant or until one of the end points is reached:
- pancreas graft failure: defined by return of hyperglycemia and resume of insulin therapy;
- patient death due to all causes with functioning graft
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of surgical engraftment.
This is measured by standard blood flow perfusion scan. Adequate blood flow is demonstrated by appropriate radioactive tracer uptake by the pancreas allograft. Lack of blood flow will prompt immediate surgical intervention.
Measured: Post-operative day 1
Track the improvement of glycemic control.
Standard of care laboratory values measured routinely include: fasting and post-prandial glucose determination, serum C-peptide levels, improvement of Hemoglobin (A1C) levels post-transplant.
Measured: Standard-of-care labs throughout duration of study
Rejection free graft survival.
Serum amylase \& lipase measured. Rising levels/aberrant glycemic control may indicate allograft rejection. Treatment - pancreas allograft rejection: 1) diagnosed by pancreas allograft biopsy; 2) if rejection, staining for C4d, repeat to DSA to determine rejection (acute antibody meditated humoral vs. acute cellular); 3) acute humoral rejection treated w/plasma exchange, then by Intravenous Immunoglobulin (IVIg) (0.5 gm/kg) every other day, daily polyclonal anti-thymocyte globulin (ATG) at 1.25 mg/kg. Treatment duration based on clinical response. Baseline immunosuppressive medications maintained during treatment.
Measured: 12 Month follow-up from baseline
Patient and graft survival.
Patient and graft survival will be calculated at this time.
Measured: At 12 Month follow-up
Secondary outcomes (3)
Tracking infection risks
Screening for viral infections will be performed according to standard of care protocol. Asymptomatic or symptomatic Cytomegalovirus (CMV) viremia will be treated in consultation with Transplant Infectious Diseases Services. Testing for bacterial and fungal infections will be guided by clinical suspicion. Active infection will again be treated in consultation with the Transplant Infectious Diseases Service.
Measured: Standard of care benchmarks through 12 months
Bleeding complications
Though increased risks for bleeding have been associated with repeated plasma exchanges that deplete clotting factors, review to evaluate whether the limited number of plasma exchanges used in the standard of care protocols will show a minimal increase of risks for bleeding. At 12 Month follow-up time points, the number of bleeding episodes, their temporal relation to plasma exchange, and frequency of requirement for factor replacement will be analyzed.
Measured: At 12 Months follow-up time points
Reversal or halting of diabetic complications
For diabetic nephropathy, serum creatinine levels and urine microalbuminuria will be measured. the use of ACE inhibitors, angiotensin receptor blocker, or aldosterone receptor blocker will be noted. For diabetic retinopathy, patients will be referred to an ophthalmologist at the 12 and 24 Months time points to measure diabetic retinal changes based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grading system.
Measured: 0, 6, 12, 18, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startDec 2006
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xunrong Luo, Northwestern University
- Investigators
- Xunrong Luo, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867386
- Sponsor's protocol ID
- STU 14940
- Other IDs
- CNV0058087
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2009
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desensitization for Highly Sensitized Recipients of Pancreas Transplantation
- ClinicalTrials.gov ID
- NCT00867386
- Acronym / sponsor ID
- STU 14940
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Mar 2009 (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.
This is an observational study for patients with type 1 diabetes, whom are already scheduled to have desensitization treatment to help increase the chance of receiving a pancreas transplant.The study staff will be looking at medical records in order to collect past, present and future information for each subject's medical condition and/or transplant. There are no additional study tests, procedures or devices needed for our analysis.
Detailed description
Please note that this study is observational. The treatment of each patient will be at the discretion of the care physician. The study investigators will ONLY be performing data collection and analysis.
Post transplant all patients will receive one additional cycle of plasma exchange with a moderate dose of Intravenous Immunoglobulin (IVIg) (0.4 mg/Kg). Antibody titers will be monitoring prior to plasma exchange and immediately following the treatment. At this point, since donor antigens are known, only antibodies to these antigens will be tested to minimize cost. We anticipate that in some patients, especially if the original titer of donor-specific antibody (DSA) was high (> 1:128), a rise in DSA will be observed following transplant. If indeed DSA will be present, additional monitoring will be initiated and the patient will be treated further with plasma exchange/IVIg cycles, with antibody monitoring before and immediately after each cycle. If no DSA are detected, patients will be monitoring on a every other day schedule for the first week; weekly for the next 3 weeks and monthly up to 6 months post transplant. Additional testing will be performed in the event of any clinical evidence of graft dysfunction, or following sever infection events.
Patient will be followed to 12 month post transplant or until one of the end points is reached:
- pancreas graft failure: defined by return of hyperglycemia and resume of insulin therapy;
- patient death due to all causes with functioning graft
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of type 1 diabetes who are highly sensitized (defined as having panel reactive antibody (PRA) level >50%) who underwent successful desensitization treatment followed by a deceased donor pancreas transplantation at NMH .
Key inclusion criteria (1 listed)
- Pancreas transplant recipients with elevated panel reactive antibody levels of >50% and who have received desensitization treatment and subsequently receive their transplantation at Northwestern Memorial Hospital (NMH).
Key exclusion criteria (1 listed)
- No Exclusion criteria exist.
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
Success of surgical engraftment.
Time frame: Post-operative day 1
This is measured by standard blood flow perfusion scan. Adequate blood flow is demonstrated by appropriate radioactive tracer uptake by the pancreas allograft. Lack of blood flow will prompt immediate surgical intervention.
Track the improvement of glycemic control.
Time frame: Standard-of-care labs throughout duration of study
Standard of care laboratory values measured routinely include: fasting and post-prandial glucose determination, serum C-peptide levels, improvement of Hemoglobin (A1C) levels post-transplant.
Rejection free graft survival.
Time frame: 12 Month follow-up from baseline
Serum amylase \& lipase measured. Rising levels/aberrant glycemic control may indicate allograft rejection. Treatment - pancreas allograft rejection: 1) diagnosed by pancreas allograft biopsy; 2) if rejection, staining for C4d, repeat to DSA to determine rejection (acute antibody meditated humoral vs. acute cellular); 3) acute humoral rejection treated w/plasma exchange, then by Intravenous Immunoglobulin (IVIg) (0.5 gm/kg) every other day, daily polyclonal anti-thymocyte globulin (ATG) at 1.25 mg/kg. Treatment duration based on clinical response. Baseline immunosuppressive medications maintained during treatment.
Patient and graft survival.
Time frame: At 12 Month follow-up
Patient and graft survival will be calculated at this time.
3 secondary outcomes
Tracking infection risks
Time frame: Standard of care benchmarks through 12 months
Bleeding complications
Time frame: At 12 Months follow-up time points
Reversal or halting of diabetic complications
Time frame: 0, 6, 12, 18, 24 Months
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 13 Mar 2014.
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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.
Xunrong Luo, MD, PhD principal investigator
Northwestern 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 Type 1 Diabetes and Rejection of Pancreas Transplant, run by Northwestern 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 1 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 13 Mar 2014. 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?
Success of surgical engraftment. (time frame: Post-operative day 1). The study lists 4 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 13 Mar 2014.