Diabetes Mellitus, Type IPhase 1/2NCT00888628
Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
A Phase 1/2 study testing Purified Pancreatic Islets and Etanercept in people with Diabetes Mellitus, Type I, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant. The primary objectives of the study are: To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type I
- What is being tested?
- Purified Pancreatic Islets and Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Aug 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects
- Age 18 to 70 years of age
- Have insulin dependent Diabetes Mellitus Type 1
- Are post-renal transplant on maintenance immunosuppression with stable renal function
- HbA1c > 7.5% or < 7.5% and hypoglycemia unawareness
Who cannot join
- Weight more than 90 kg
- Insulin requirement > 60 Units/day
- Other (non-kidney) organ transplants except prior failed pancreatic graft.
- Untreated or unstable proliferative diabetic retinopathy
- Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
- Active infection
Show all 20Show fewer
- Negative screen for Epstein-Barr virus (EBV)
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- History of Factor V Leiden mutation
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with international normalized ratio (INR) > 1.5
- Severe co-existing cardiac disease
- Persistent elevation of liver function tests at the time of study entry
- Acute or chronic pancreatitis
- Male subjects with elevation of prostate specific antigen
- Pregnancy
- Positive screen for polyoma (BK) virus
- Untreated hyperlipidemia
- Recent hemorrhagic stroke
- Factors associated with an increased risk of bleeding
- Contact PI for complete Incl-Excl criteria list.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.
The primary objectives of the study are:
- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works
The Secondary objective of the study is:
- To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes
Read the detailed description
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
- Conditions
- Diabetes Mellitus, Type I
- Being tested
- Purified Pancreatic Islets, Etanercept
- Keywords
- Type I diabetes, Islet after Kidney Transplant, 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.
Purified Pancreatic IsletsBiological
Islet after kidney transplant in patients with type I diabetes.
EtanerceptDrug
Given as induction for islet cell transplant
| Study group | Role | What they receive |
|---|---|---|
| Islet transplant | Experimental | Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.
For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.
Induction therapy for subsequent transplants will be 2 doses of basiliximab.
All patients will receive Etanercept to promote engraftment. Receives: Biological: Purified Pancreatic Islets; Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.
Measured: 1 year after the subject's first islet transplant
Secondary outcomes (8)
Number of Participants With a Decrease in HbA1c
Subjects will have a decrease in HbA1c of at least >1%
Measured: 1 year after subject's first islet transplant
Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine
Proteinuria and serum creatinine will be stable or decreased as compared to pre-transplant values
Measured: 1 year after subjects initial islet transplant
An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction
Measured: 1 year after the subject's first islet transplant
Impact on Vision
Improvement of frequency of interventions and from changes in reported visual acuity with optical refraction and severity of diabetic retinopathy
Measured: 1 year after the subject's first islet transplant
Absence of Negative Renal Impact Measures
Loss of allograft survivial (return to dialysis, retransplant, death) and Renal allograft function meausred by SCr
Measured: 1 year after the subject's first islet transplant
Improvement of Metabolic Control
Whether there is an improvement in metabolic control in IAK will be evaluated based on improvement in
- basal c-peptide levels,
- MMTT,
- insulin requirements, and
- c-peptide to glucose, creatinine ratio (CPGCR).
Measured: 1 year after the subject's first islet transplant
Number of Participants With a Decrease of Severe Hypoglycemic Events
Subjects will have a decrease in severe hypoglycemic events
Measured: 1 year after subject's first transplant
Reduction of Insulin Requriements
Evidence of partial success will be considered for subjects who have a reduction in insulin requirements but who are not insulin independent. This will be assessed by comparing the pre-transplant insulin requirement expressed as insulin units per kg per day with the requirement preceding subsequent islet transplants and the insulin requirements at 6 months and 1, 2, and 3 years after the first and last transplant.
Measured: 1 year after the subject's first islet transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type IStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)
- Responsible party
- Principal investigator, James F. Markmann, MD, PhD, Massachusetts General Hospital
- Investigators
- James F Markmann, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888628
- Sponsor's protocol ID
- IAK
- Status last verified
- Oct 2017
- First submitted
- 23 Apr 2009
- Last updated
- 29 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients
- ClinicalTrials.gov ID
- NCT00888628
- Acronym / sponsor ID
- IAK
- Conditions
- Diabetes Mellitus, Type I
- Keywords
- Type I diabetes, Islet after Kidney Transplant, Islet transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)
- Study start
- May 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Posted 27 Jan 2017
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 the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.
The primary objectives of the study are:
- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works
The Secondary objective of the study is:
- To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes
Detailed description
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Islet transplant | Experimental | Biological: Purified Pancreatic Islets, Drug: EtanerceptPatients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2 doses of basiliximab. All patients will receive Etanercept to promote engraftment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects
- Age 18 to 70 years of age
- Have insulin dependent Diabetes Mellitus Type 1
- Are post-renal transplant on maintenance immunosuppression with stable renal function
- HbA1c > 7.5% or < 7.5% and hypoglycemia unawareness
Key exclusion criteria (20 listed)
- Weight more than 90 kg
- Insulin requirement > 60 Units/day
- Other (non-kidney) organ transplants except prior failed pancreatic graft.
- Untreated or unstable proliferative diabetic retinopathy
- Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
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 |
|---|---|---|
| Purified Pancreatic IsletsIslet after kidney transplant in patients with type I diabetes. | Biological | Islet transplant |
| EtanerceptGiven as induction for islet cell transplant | Drug | Islet transplant |
Primary outcome
Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.
Time frame: 1 year after the subject's first islet transplant
8 secondary outcomes
Number of Participants With a Decrease in HbA1c
Time frame: 1 year after subject's first islet transplant
Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine
Time frame: 1 year after subjects initial islet transplant
An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction
Time frame: 1 year after the subject's first islet transplant
Impact on Vision
Time frame: 1 year after the subject's first islet transplant
Absence of Negative Renal Impact Measures
Time frame: 1 year after the subject's first islet transplant
Improvement of Metabolic Control
Time frame: 1 year after the subject's first islet transplant
Number of Participants With a Decrease of Severe Hypoglycemic Events
Time frame: 1 year after subject's first transplant
Reduction of Insulin Requriements
Time frame: 1 year after the subject's first islet transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 F Markmann, MD, PhD principal investigator
Massachusetts General Hospital
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 Purified Pancreatic Islets and Etanercept in people with Diabetes Mellitus, Type I, run by Massachusetts General 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 5 inclusion and 20 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 29 Nov 2017. 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.
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?
Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant. (time frame: 1 year after the subject's first islet 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 29 Nov 2017.