Efficacy of Islet After Kidney Transplantation

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess the benefit of islet transplantation in type 1 diabetic (T1D) kidney transplant recipients.

Key facts

Study ID

NCT00468117

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Starts

2007-01-01

Expected to finish

2017-07-05

Last updated by the study team

2017-10-20

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mentally stable and able to comply with study procedures;
• Clinical history compatible with type 1 diabetes with onset of disease at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28;
• Absent stimulated C-peptide (defined as less than 0.3 ng/ml) 60 and 90 minutes post-mixed-meal tolerance test;
• Received kidney transplant for ESRD and are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppressive therapy;
• Stable renal function as defined as creatinine of no more than one third greater than the average creatinine determination performed in the 3 previous months prior to islet transplantation, until rejection, obstruction or infection is ruled out;
• Intensive diabetes management followed by reduced awareness of hypoglycemia or an HbA1c ≥ 7.5%.

You may not qualify if…

• Body mass index (BMI) greater than 30 kg/m2 or weight more than 90 kg;
• Insulin requirement of >1.0 IU/kg/day or <15 U/day;
• Other (non-kidney) organ transplants except prior failed pancreatic graft where the graft failed within the first two weeks due to thrombosis, followed by pancreatectomy and the pancreas transplant occurred more than 6 months prior to enrollment;
• Untreated proliferative diabetic retinopathy;
• Systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg;
• Calculated glomerular filtration rate of less than 40 ml/min/1.73meter-squared. More information about this criterion is in the protocol;
• Proteinuria (albumin/creatinine ratio or ACr > 300 mg/g) of new onset since kidney transplantation;
• Either Class I or Class II panel-reactive anti-HLA antibodies > 50%; Participants with either Class I or Class II panel reactive anti-HLA antibodies of 50% or less will be excluded if any of the following are detected:
• Positive cross match;
• Islet donor-directed anti-HLA antibodies detected my Luminex Single Antigen/specificity bead assay, including weakly reactive antibodies that would not be detected by a flow cross-match; or
• Antibodies to the renal donor (i.e. presumed de novo).
• Pregnant, breastfeeding, or unwilling to use effective contraception throughout the study and 4 months after study completion;
• Active infection, including hepatitis B, hepatitis C, HIV, or tuberculosis. More information about this criterion is in the protocol.
• Negative for Epstein-Barr virus (EBV) by (VCA) IgG determination;
• Invasive aspergillus infection, histoplasmosis, and coccidioidomycosis infection one year prior to study enrollment;
• History of malignancy except for completely resected squamous or basal cell carcinoma of the skin;
• Known active alcohol or substance abuse;
• History of Factor V Leiden mutation;
• Any coagulopathy or medical condition requiring long-term anticoagulant therapy after transplantation or individuals with an INR greater than 1.5;
• Severe co-existing cardiac disease, characterized by any one of these conditions:
• Recent MI (within past 6 months);
• Evidence of ischemia on functional cardiac exam within the last year;
• Left ventricular ejection fraction < 30%; or
• Valvular disease requiring replacement with prosthetic valve.
• Persistent elevation of liver function tests at the time of study entry. Persistent serum glutamic-oxaloacetic transaminase (SGOT [AST]), serum glutamate pyruvate transaminase (SGPT [ALT],) alkaline phosphatase or total bilirubin, with values > 1.5 times normal upper limits will exclude a subject;

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Emory Universtiy — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States
• University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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