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| Name | Class |
|---|---|
| Boston Area Diabetes Endocrinology Research Center (funded by NIDDK) | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purified Pancreatic Islets | Biological | Islet after kidney transplant in patients with type I diabetes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after the subject's first islet transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Decrease in HbA1c | Subjects will have a decrease in HbA1c of at least >1% | 1 year after subject's first islet transplant |
| Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine |
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Inclusion Criteria:
Exclusion Criteria:
Contact PI for complete Incl-Excl criteria list.
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| Name | Affiliation | Role |
|---|---|---|
| James F Markmann, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Islet Transplant | 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. Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes. Etanercept: Given as induction for islet cell transplant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Islet Transplant | 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. Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes. Etanercept: Given as induction for islet cell transplant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 1 year after the subject's first islet transplant |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Islet Transplant | 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. Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes. Etanercept: Given as induction for islet cell transplant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction (Elevated Temp 104.7) | General disorders | Systematic Assessment | Elevated temp during Thymoglobulin infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James F. Markmann, M.D. Ph.D - Chief, Division of Transplant Surgery | Massachusetts General Hospital | 617-643-4087 | kcrisalli@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Etanercept | Drug | Given as induction for islet cell transplant |
|
Proteinuria and serum creatinine will be stable or decreased as compared to pre-transplant values
| 1 year after subjects initial islet transplant |
| An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction | 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 | 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 | 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
| 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 | 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. | 1 year after the subject's first islet transplant |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With a Decrease in HbA1c | Subjects will have a decrease in HbA1c of at least >1% | Posted | Count of Participants | Participants | 1 year after subject's first islet transplant |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 1 year after subjects initial islet transplant |
|
|
|
| Secondary | An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction | Posted | Count of Participants | Participants | 1 year after the subject's first islet transplant |
|
|
|
| Secondary | Impact on Vision | Improvement of frequency of interventions and from changes in reported visual acuity with optical refraction and severity of diabetic retinopathy | Posted | Count of Participants | Participants | 1 year after the subject's first islet transplant |
|
|
|
| Secondary | Absence of Negative Renal Impact Measures | Loss of allograft survivial (return to dialysis, retransplant, death) and Renal allograft function meausred by SCr | Posted | Count of Participants | Participants | 1 year after the subject's first islet transplant |
|
|
|
| Secondary | Improvement of Metabolic Control | Whether there is an improvement in metabolic control in IAK will be evaluated based on improvement in
| Posted | Count of Participants | Participants | 1 year after the subject's first islet transplant |
|
|
|
| Secondary | Number of Participants With a Decrease of Severe Hypoglycemic Events | Subjects will have a decrease in severe hypoglycemic events | Posted | Count of Participants | Participants | 1 year after subject's first transplant |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 year after the subject's first islet transplant |
|
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|
| 3 |
| 4 |
| 4 |
| 4 |
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| Soft tissue infection | Infections and infestations | Systematic Assessment | Soft tissue infection of foot. This is an exacerbation of a pre-existing condition |
|
| Hyperkalemia | Investigations | Systematic Assessment |
|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Hypertenstion | Cardiac disorders | Systematic Assessment |
|
| Elevated Creatinine | Renal and urinary disorders | Systematic Assessment | Elevated Creatinine, resolved. |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Recurrent UTIs at baseline |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |