This trial is active, not recruiting.

Condition diabetes mellitus, type i
Treatments purified pancreatic islets, etanercept
Phase phase 1/phase 2
Sponsor Massachusetts General Hospital
Collaborator Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)
Start date May 2009
End date March 2016
Trial size 4 participants
Trial identifier NCT00888628, IAK


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
Given as induction for islet cell transplant

Primary Outcomes

The safety of islets isolated at Massachusetts General Hospital (MGH) and the proportion of insulin independent subjects
time frame: 1 year after the subject's first islet transplant

Secondary Outcomes

HbA1c and number of hypoglycemic events
time frame: 1 year after subject's first islet transplant
Urinary albumin and creatinine ratio and serum creatinine
time frame: 1 year after subjects initial islet transplant
Cardiovascular events, CVA, and MI
time frame: 1 year after the subject's first islet transplant
Impact on vision
time frame: 1 year after the subject's first islet tranplant
Renal impact measures including renal allograft survival
time frame: 1 year after the subject's first islet transplant
Measures of metabolic control
time frame: 1 year after the subject's first islet transplant

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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 BK virus - Untreated hyperlipidemia - Recent hemorrhagic stroke - Factors associated with an increased risk of bleeding Contact PI for complete Incl-Excl criteria list.

Additional Information

Official title Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients
Principal investigator James F Markmann, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.