Calcineurin Inhibitor-free, Steroid-free Immunosuppressive Regimen in Simultaneous Islet-Kidney Transplantation for Uremic Type 1 Diabetic Patients
Withdrawn before enrolling · Not applicable
Conditions studied: Islets of Langerhans Transplantation, Diabetes Mellitus, Type 1, Kidney Transplantation
In brief
The investigators hypothesize that a calcineurin inhibitor-free, steroid-free, co-stimulatory blockade-based immunosuppressive regimen, in combination with a GLP-1 agonist, will reduce the islet mass required to achieve and sustain insulin independence following simultaneous islet-kidney transplantation.
Key facts
- Study ID
- NCT01033500
- Run by
- University of Wisconsin, Madison
- People needed
- 0
- Starts
- 2010-07-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2013-05-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects will include those with Type 1 Diabetes Mellitus, undergoing kidney transplantation, and:
- are closely followed by a primary care provider and/or endocrinologist for >6 months prior to enrollment in the trial
- do not have psychogenic factors which preclude therapeutic compliance
- have a fasting C-peptide of <0.2 ng/mL• have diabetes for >5 years • are between 18 and 65 years of age
- have a creatinine clearance of less than 20 mL/min
- have a body mass index of less than or equal to 28
- In the case of women of childbearing potential (WOCBP), must have a negative pregnancy test and avoid pregnancy throughout the study and 8 weeks after final dose of study drug.
- WOCBP must use two adequate methods of contraception.
- A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy.
You may not qualify if…
- Untreated proliferative diabetic retinopathy
- HgbA1C >12
- creatinine clearance > 20 ml/minute
- presence of panel reactive antibodies (PRA) >20% (per CDC-based assay)
- malignancy or previous malignancy, except for adequately treated skin cancers (basal cell or squamous cell carcinoma) within the past 5 years
- sensitivity to iodine and/or shellfish (re: Iothalamate-based GFR testing)
- x-ray evidence of pulmonary infection
- active infections
- active peptic ulcer disease, gall stones, hemangioma, cirrhosis or portal hypertension
- serological evidence of HIV, HBSAg or HCV
- abnormal liver function tests (elevated AST and ALT > 2x upper limit of normal)
- anemia (hemoglobin) <9 gm/dl
- serum triglycerides >200 mg/dl
- serum cholesterol >240 mg/dl
- body mass index above 28
- unstable cardiovascular status (including positive stress echocardiography if >age 35); severe coexisting cardiac disease, myocardial infarction within the 6 months prior to enrollment in the study, left ventricular ejection fraction of <30%, or evidence of ongoing ischemia
- prostate specific antigen (PSA) >4 in males >40 years old or with family history of prostate cancer
- pregnancy or breastfeeding
- sexually-active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable)
- alcohol abuse, substance abuse or smoking within the previous 6 months
- insulin requirement >1.5 u/kg/day
- negative for Epstein-Barr virus by IgG determination
- history of factor V deficiency
- acute or chronic pancreatitis
- recurrent attenuated vaccine(s) within the previous 2 months
Where it is running
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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