Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes (NCT00708604) | Clinical Trial Compass
CompletedPhase 1
Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes
United States3 participantsStarted 2008-10-18
Plain-language summary
The purpose of this study is to determine the safety of islet transplantation in patients with type 1 diabetes who have had a successful kidney transplant and have been maintained for at least three months on anti-rejection medications consisting of any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg/day or less). Another purpose is to determine the effectiveness of an islet transplant in inducing insulin independence and whether or not an islet transplant improves quality of life for kidney transplants patients with type 1 diabetes.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide (a basal level of \</= 0.2 ng/ml before IV administration of 1 mg of glucagon, and a glucagon stimulated C-peptide \</= 0.8 ng/ml) and diagnosis of diabetes for at least 5 years.
* Recipient of renal transplant with good function (serum creatinine \</= 1.6 mg/dl, creatinine clearance \>/=60 ml/min and albumin excretion \</= 300 mg/24 hr) for \>3 months.
* Stable immunosuppression consisting of any combination of sirolimus, tacrolimus, MMF or \</= 5 mg/day of corticosteroids for at least 3 months, without major complications.
* No history of acute rejection episodes related to renal graft in last 12 months and low risk for developing acute rejection (first renal transplant, PRA \<25%, negative kidney crossmatch by B, T, flow cytometry)
* Under the continuing care of a renal transplant nephrologist/surgeon.
* No evidence of liver disease (liver enzymes \< twice the upper limit of normal for each of ALT and AST, bilirubin \< 2 mg/dl, albumin \> 3.5 g/dl, and PT and PTT \</= 1.1 x the upper limit of normal).
* Ability to comply with post-transplant regimen, including immunosuppression, insulin pump therapy and metabolic testing. Patients will be required to perform self-monitoring of blood glucose a minimum of four times daily, and provide complete records of blood glucose levels and insulin doses.
* Ability to give informed consent.
* Age greater than or equal to 18 years or…
What they're measuring
1
Percent of subjects who have achieved insulin sufficiency post transplant.