Type 1 Diabetes MellitusPhase 1/2NCT02520076
Aralast NP in Islet Transplant
A Phase 1/2 study testing Alpha-1 Antitrypsin in people with Type 1 Diabetes Mellitus, run by University of Alberta at 1 site in Canada.
Trial summary
Islet transplantation is a relatively new procedure used in people with difficult to control Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas donated by the next of kin of a person who is brain dead. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Alpha-1 Antitrypsin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to 30 Sep 2019
- Phase
- Phase 1/2
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible the participant must have had Type 1 Diabetes Mellitus (T1DM) for more than 5 years, complicated by at least 1 of the following situations that persist despite intensive insulin management efforts:
- Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels < 3.0 mmol/L, indicated by, 1 or more episodes of severe hypoglycemia requiring third party assistance within 12 months, a Clarke score ≥4, HYPO score ≥1,000, lability index (LI) ≥400 or combined HYPO/LI >400/>300.
- Metabolic instability, characterized by erratic blood glucose levels that interfere with daily activities and or 1 or more hospital visits for diabetic ketoacidosis over the last 12 months.
- Participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
Who cannot join
- Hypersensitivity to Aralast NP, history of immunoglobulin A (IgA) deficiency, or assessed low IgA (< 0.70 g/L).
- Severe co-existing cardiac disease, characterized by any one of these conditions: (a) recent (within the past 6months) myocardial infarction; (b) left ventricular ejection fraction <30%; or (c) evidence of ischemia on functional cardiac exam.
- Active alcohol or substance abuse, to include cigarette smoking (must be abstinent for 6 months prior to listing for transplant).
- Psychiatric disorder making the subject not a suitable candidate for transplantation, (e.g., schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medication).
- History of non-adherence to prescribed regimens.
- Active infection including Hepatitis C, Hepatitis B, HIV, or tuberculosis (TB) (subjects with a positive purified protein derivative (PPD) performed within one year of enrollment, and no history of adequate chemoprophylaxis).
Show all 24Show fewer
- Any history of, or current malignancies except squamous or basal skin cancer.
- BMI > 35 kg/m2 at screening visit.
- Age less than 18 or greater than 68 years.
- Measured glomerular filtration rate <60 mL/min/1.73 m2.
- Presence or history of macroalbuminuria (>300 mg/g creatinine).
- Clinical suspicion of nephritic (hematuria, active urinary sediment) or rapidly progressing renal impairment (e.g. Increase in serum creatinine of 25% within the last 3-6 months).
- Baseline Hb < 105 g/L in women, or < 120 g/L in men.
- Baseline screening liver function tests (LFT) outside of normal range, with the exception of uncomplicated Gilbert's Syndrome. An initial LFT panel with any values >1.5 times the upper limit of normal (ULN) will exclude a patient without a re-test; a re-test for any values between ULN and 1.5 times ULN should be made, and if the values remain elevated above normal limits, the patient will be excluded.
- Untreated proliferative retinopathy.
- Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast-feeding.
- Previous transplant or evidence of significant sensitization on panel reactive antibody (PRA) (at the discretion of the investigator).
- Insulin requirement >1.0 U/kg/day
- Hemoglobin A1c (HbA1c) >12%.
- Uncontrolled hyperlipidemia [fasting LDL cholesterol > 3.4 mmol/L, treated or untreated; and/or fasting triglycerides > 2.3 mmol/L)].
- Under treatment for a medical condition requiring chronic use of steroids.
- Use of coumadin or other anticoagulant therapy (except aspirin) or subject with prothrombin time / international normalized ratio (PT/INR) > 1.5.
- Untreated Celiac disease.
- Patients with Graves disease will be excluded unless previously adequately treated with radioiodine ablative therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Single Donor Success Rate in Clinical Islet Transplantation Using Alpha-1 Antitrypsin (Aralast NP)
Islet transplantation is a relatively new procedure used in people with difficult to control Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas donated by the next of kin of a person who is brain dead. After the cells are prepared, the islets are transplanted into the recipient's liver and produce insulin. Patients who receive an islet transplant take medication that suppresses their immune system and prevent rejection of the islet tissue.
The investigators have also learned that there is general inflammation at the time of the transplant that is not fully controlled with our standard medications. The investigators believe this inflammation may cause some islet cell death around the time of transplant. Due to this islet death around the time of transplant, most recipients need 2 or 3 separate transplant procedures.
Read more
The investigators are studying the use of Alpha-1 Antitrypsin (AAT) in islet transplant to decrease the amount of cell death caused by general inflammation. In this study, the investigators hope to decrease the need for more than one transplant procedure by controlling inflammation, before and after transplant, with Alpha-1 Antitrypsin (Aralast NP).
Alpha-1 Antitrypsin is a protein made in healthy humans that helps to prevent tissue damage during times of inflammation. Alpha-1 Antitrypsin is obtained from healthy plasma donors. There have been studies in Islet Transplant in monkeys using this medication and it has shown to protect the islets from inflammation.
This study involves using Alpha-1 Antitrypsin in addition to our current Standard of Care medications used in Islet Transplant.
Read the detailed description
METHODS \& PROCEDURES:
This clinical trial will be a non-randomized, open-label, single arm, prospective trial to asses the efficacy of AAT in preventing non-immunologic loss of transplanted islet mass in a single-donor islet transplant. Enrolled patients (n=12) will participate in the study for 1 year, with outcomes assessed during islet isolation, 90 days post-transplant and at 1 year post-transplant.
The current Standard of Care treatment for Islet Transplant includes induction (Alemtuzumab/Basiliximab) and long-term immunosuppression (Prograf/Cellcept). The engraftment regimen includes anti-inflammatory medications (Etanercept/Anakinra) and intravenous insulin and heparin. We will utilize the current Islet Standard of Care Protocol. The only additional intervention used in this pilot trial is the addition of the investigational agent, alpha-1-antitrypsin to islet processing, culture, and patient treatment pre- and post-transplant.
Islet Dosage and Culture
Islets will be treated with AAT (to a final dilution of 0.5mg/mL) throughout the isolation and culture process. Islet treatment will include:
- Flushing through the superior mesenteric artery and splenic artery (final dilution 0.5mg/mL)
- Culturing with AAT (final dilution 0.5mg/mL)
Participant Dosing
Subjects undergoing intraportal clinical islet transplantation will receive treatment (AAT at 120mg/kg intravenously, based on Day -1 admission weight and rounded to the nearest 20mg) at the following time points:
- Day -1 prior to transplant
- Day 3 post-transplant
- Day 7 post-transplant
- Day 14 post-transplant Recipient management including the transplant procedure, postoperative care, immunosuppression and other medications, and post-transplant monitoring will follow standard of care protocols.
SCOPE \& DURATION:
Recruitment will take place at the Clinical Islet Transplant Program at the University of Alberta Hospital, Edmonton, Alberta. Participants (N=12) will be adult patients, assessed and deemed appropriate to activate on the waiting list for islet transplantation. Anticipated duration of enrollment is 12 months, with follow-up at 90 days and 12 months.
In this pilot study control data will be obtained from a Standard of Care control cohort as comparison.
We will also obtain 2 year and 3 year long-term follow-up data from standard of care testing. This long-term follow up will review data collected within 3 years post-transplant and will include the following: patient and graft survival data, biochemical data from routine blood work, routine and for cause imaging, metabolic testing, initiation of interventions to treat complications, and reporting of any adverse or serious adverse events.
STUDY FOLLOWUP:
As follow-up, this study will use a number of blood tests and parameters used by the clinical program. We will obtain the following information regarding participant outcomes from routine blood testing, metabolic testing, and clinic visits:
- Complete blood count (CBC)-differential to monitor white and red blood cells
- Liver function tests
- Kidney function tests
- Blood sugar tests, including the Hemoglobin A1c (HbA1c) which estimates average blood sugars over 3 months.
- C-peptide testing, a chemical produced only be healthy, working islets.
These clinics will occur weekly x 4weeks, then at 1 month, 3 months, 6, months and 12 months. Participants will then have annual clinic visits, all as standard of care. Clinic visits include vital signs, physician assessment, review of recorded blood glucose records, and determination of patient requiring insulin or becoming insulin independent by a set of criteria based on the above blood sugar testing and glucose records.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Alpha-1 Antitrypsin
- Keywords
- Islet Transplantation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-1 AntitrypsinDrug
Subjects will receive their islets treated with Aralast NP during islet isolation process.
Subjects will receive Aralast NP at a dose of 120 mg/kg (at an infusion rate of 0.2 mL/kg/min or less), dependent on patient tolerance, based on Day -1 admission weight and dose rounded to the nearest 20 mg) at the following time points:
- Pre-transplant Day -1
- Post-transplant Day 3
- Post-transplant Day 7
- Post-transplant Day 14
| Study group | Role | What they receive |
|---|---|---|
| AAT treated group | Experimental | Study subjects will receive Alpha-1 Antitrypsin (AAT) study drug intravenously in 4 doses over 15 days around the time of their transplant. The islets will also be prepared in a solution of AAT. Receives: Drug: Alpha-1 Antitrypsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate AAT efficacy in preventing non-immunologic loss of transplanted islet mass in a single-donor islet transplant.
Insulin independence at day 90 post-transplant (initial, single-donor transplant)
Measured: Day 90 post-transplant
Secondary outcomes (4)
To demonstrate safety of AAT during islet isolation and culture
Post-isolation measurements, compared to current standard protocol isolation data, for the following parameters:
- Endotoxin level
- Microbiological culture [bacterial (both aerobic and anaerobic), fungal, mycoplasma, and mycobacterium culture]
Measured: Day -1 pre-transplant
To demonstrate efficacy of AAT to improve islet isolation quantity and quality
Post-isolation measurements, compared to current standard protocol isolation data, for the following parameters:
- Islet yield
- Viability (SytoGreen/ethidium bromide)
- Purity
- Beta cell specific viability
- Cell composition assay
- Glucose stimulated insulin release
- DNA content
Measured: Day -1 pre-transplant
To demonstrate safety of AAT in islet transplantation.
Adverse Event/Serious Adverse Event morbidity within 1 year post-transplant, which includes the following:
- Primary non-function (PNF)
- End-organ dysfunction
- Malignancy
- Opportunistic infection
- Inpatient hospitalization
- Prolongation of existing hospitalization
- A life-threatening event
- Persistent or significant disability
- Congenital anomaly or birth defect
- Patient death
Measured: Year 1 post-transplant
To demonstrate AAT efficacy in the prevention of long-term metabolic burn-out.
- Full graft function at 1 year after initial single-donor transplant, compared to retrospective controls (current standard of care induction).
- Partial graft function at 1 year after initial single-donor transplant compared to retrospective controls (current standard of care induction).
Measured: Year 1 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- James Shapiro, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520076
- Sponsor's protocol ID
- Pro00047923
- Status last verified
- Oct 2019
- First submitted
- 6 Aug 2015
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Single Donor Success Rate in Clinical Islet Transplantation Using Alpha-1 Antitrypsin (Aralast NP)
- ClinicalTrials.gov ID
- NCT02520076
- Acronym / sponsor ID
- Pro00047923
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Islet Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Aug 2015
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 11 Aug 2015 (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.
Islet transplantation is a relatively new procedure used in people with difficult to control Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas donated by the next of kin of a person who is brain dead. After the cells are prepared, the islets are transplanted into the recipient's liver and produce insulin. Patients who receive an islet transplant take medication that suppresses their immune system and prevent rejection of the islet tissue.
The investigators have also learned that there is general inflammation at the time of the transplant that is not fully controlled with our standard medications. The investigators believe this inflammation may cause some islet cell death around the time of transplant. Due to this islet death around the time of transplant, most recipients need 2 or 3 separate transplant procedures.
The investigators are studying the use of Alpha-1 Antitrypsin (AAT) in islet transplant to decrease the amount of cell death caused by general inflammation. In this study, the investigators hope to decrease the need for more than one transplant procedure by controlling inflammation, before and after transplant, with Alpha-1 Antitrypsin (Aralast NP).
Alpha-1 Antitrypsin is a protein made in healthy humans that helps to prevent tissue damage during times of inflammation. Alpha-1 Antitrypsin is obtained from healthy plasma donors. There have been studies in Islet Transplant in monkeys using this medication and it has shown to protect the islets from inflammation.
This study involves using Alpha-1 Antitrypsin in addition to our current Standard of Care medications used in Islet Transplant.
Detailed description
METHODS \& PROCEDURES:
This clinical trial will be a non-randomized, open-label, single arm, prospective trial to asses the efficacy of AAT in preventing non-immunologic loss of transplanted islet mass in a single-donor islet transplant. Enrolled patients (n=12) will participate in the study for 1 year, with outcomes assessed during islet isolation, 90 days post-transplant and at 1 year post-transplant.
The current Standard of Care treatment for Islet Transplant includes induction (Alemtuzumab/Basiliximab) and long-term immunosuppression (Prograf/Cellcept). The engraftment regimen includes anti-inflammatory medications (Etanercept/Anakinra) and intravenous insulin and heparin. We will utilize the current Islet Standard of Care Protocol. The only additional intervention used in this pilot trial is the addition of the investigational agent, alpha-1-antitrypsin to islet processing, culture, and patient treatment pre- and post-transplant.
Islet Dosage and Culture
Islets will be treated with AAT (to a final dilution of 0.5mg/mL) throughout the isolation and culture process. Islet treatment will include:
- Flushing through the superior mesenteric artery and splenic artery (final dilution 0.5mg/mL)
- Culturing with AAT (final dilution 0.5mg/mL)
Participant Dosing
Subjects undergoing intraportal clinical islet transplantation will receive treatment (AAT at 120mg/kg intravenously, based on Day -1 admission weight and rounded to the nearest 20mg) at the following time points:
- Day -1 prior to transplant
- Day 3 post-transplant
- Day 7 post-transplant
- Day 14 post-transplant Recipient management including the transplant procedure, postoperative care, immunosuppression and other medications, and post-transplant monitoring will follow standard of care protocols.
SCOPE \& DURATION:
Recruitment will take place at the Clinical Islet Transplant Program at the University of Alberta Hospital, Edmonton, Alberta. Participants (N=12) will be adult patients, assessed and deemed appropriate to activate on the waiting list for islet transplantation. Anticipated duration of enrollment is 12 months, with follow-up at 90 days and 12 months.
In this pilot study control data will be obtained from a Standard of Care control cohort as comparison.
We will also obtain 2 year and 3 year long-term follow-up data from standard of care testing. This long-term follow up will review data collected within 3 years post-transplant and will include the following: patient and graft survival data, biochemical data from routine blood work, routine and for cause imaging, metabolic testing, initiation of interventions to treat complications, and reporting of any adverse or serious adverse events.
STUDY FOLLOWUP:
As follow-up, this study will use a number of blood tests and parameters used by the clinical program. We will obtain the following information regarding participant outcomes from routine blood testing, metabolic testing, and clinic visits:
- Complete blood count (CBC)-differential to monitor white and red blood cells
- Liver function tests
- Kidney function tests
- Blood sugar tests, including the Hemoglobin A1c (HbA1c) which estimates average blood sugars over 3 months.
- C-peptide testing, a chemical produced only be healthy, working islets.
These clinics will occur weekly x 4weeks, then at 1 month, 3 months, 6, months and 12 months. Participants will then have annual clinic visits, all as standard of care. Clinic visits include vital signs, physician assessment, review of recorded blood glucose records, and determination of patient requiring insulin or becoming insulin independent by a set of criteria based on the above blood sugar testing and glucose records.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAT treated group | Experimental | Drug: Alpha-1 AntitrypsinStudy subjects will receive Alpha-1 Antitrypsin (AAT) study drug intravenously in 4 doses over 15 days around the time of their transplant. The islets will also be prepared in a solution of AAT. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be eligible the participant must have had Type 1 Diabetes Mellitus (T1DM) for more than 5 years, complicated by at least 1 of the following situations that persist despite intensive insulin management efforts:
- Participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
Key exclusion criteria (24 listed)
- Hypersensitivity to Aralast NP, history of immunoglobulin A (IgA) deficiency, or assessed low IgA (< 0.70 g/L).
- Severe co-existing cardiac disease, characterized by any one of these conditions: (a) recent (within the past 6months) myocardial infarction; (b) left ventricular ejection fraction <30%; or (c) evidence of ischemia on functional cardiac exam.
- Active alcohol or substance abuse, to include cigarette smoking (must be abstinent for 6 months prior to listing for transplant).
- Psychiatric disorder making the subject not a suitable candidate for transplantation, (e.g., schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medication).
- History of non-adherence to prescribed regimens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-1 AntitrypsinSubjects will receive their islets treated with Aralast NP during islet isolation process. Subjects will receive Aralast NP at a dose of 120 mg/kg (at an infusion rate of 0.2 mL/kg/min or less), dependent on patient tolerance, based on Day -1 admission weight and dose rounded to the nearest 20 mg) at the following time points: * Pre-transplant Day -1 * Post-transplant Day 3 * Post-transplant Day 7 * Post-transplant Day 14 | Drug | AAT treated group |
Primary outcome
To demonstrate AAT efficacy in preventing non-immunologic loss of transplanted islet mass in a single-donor islet transplant.
Time frame: Day 90 post-transplant
Insulin independence at day 90 post-transplant (initial, single-donor transplant)
4 secondary outcomes
To demonstrate safety of AAT during islet isolation and culture
Time frame: Day -1 pre-transplant
To demonstrate efficacy of AAT to improve islet isolation quantity and quality
Time frame: Day -1 pre-transplant
To demonstrate safety of AAT in islet transplantation.
Time frame: Year 1 post-transplant
To demonstrate AAT efficacy in the prevention of long-term metabolic burn-out.
Time frame: Year 1 post-transplant
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 24 May 2022.
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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.
James Shapiro, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alpha-1 Antitrypsin in people with Type 1 Diabetes Mellitus, run by University of Alberta at 1 site in Canada.
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 4 inclusion and 24 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 24 May 2022. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 demonstrate AAT efficacy in preventing non-immunologic loss of transplanted islet mass in a single-donor islet transplant. (time frame: Day 90 post-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 24 May 2022.