Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)
• Treatments: Etanercept

Criteria

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.