Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/1/2017 |
| Start Date: | May 2009 |
| End Date: | August 2016 |
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
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
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
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