Status:
COMPLETED
Islet Transplantation in Type 1 Diabetic Recipients of Kidney Transplants
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Joslin Diabetes Center
Conditions:
Diabetes
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Study hypothesis is that we can reproduce results of islet transplantation in type one diabetics in patients with a kidney transplant.
Detailed Description
This trial is designed to replicate the protocol currently being tested by the Immune Tolerance Network (ITN) in a population of patients that have been previously transplanted (recipients of function...
Eligibility Criteria
Inclusion
- Enrolling subjects must have Type 1 diabetes mellitus for more than 5 years, complicated by renal failure requiring a kidney transplant. The complicating situations are:
- Reduced awareness of hypoglycemia,
- Metabolic lability/instability,
- Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by:
- i) Retinopathy- ii) Nephropathy- or
- iii) Neuropathy-
Exclusion
- Severe co-existing cardiac disease, characterized by any one of these conditions:
- recent myocardial infarction (within past 6 months), or
- angiographic evidence of non-correctable coronary artery disease, or
- evidence of ischemia on functional cardiac exam (•
- Active alcohol or substance abuse-includes cigarette smoking (
- Failure to fulfill major work, school, or home responsibilities;
- Drinking in situations that are physically dangerous, such as while driving a car or operating machinery;
- Recurring alcohol-related legal problems, such as being arrested for driving under the influence of alcohol or for physically hurting someone while drunk;
- Continued drinking despite having ongoing relationship problems that are caused or worsened by the effects of alcohol.
- Psychiatric disorder making the subject not a suitable candidate for transplantation,
- History of non-adherence to prescribed regimens
- Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB)
- Any history of malignancy except squamous or basal skin cancer
- BMI \> 26 kg/m2 or body weight \> 70 kg for females and \> 75kg for males at the screening visit. (An allowance for weight gain of up to +2 kg body weight is permitted between the screening visit and actual transplant. No transplant can be given to a female subject weighing \> 72 kg or a male subject weighing \> 77kg on the day of transplant. See Section 5.1 for minimum islet equivalent infusion requirements per recipient body weight.)
- C-peptide response to arginine stimulation (5 gm I.V.) (any C-peptide ≥ 0.3 ng/mL at 2, 3, 4, 5, 7 and 10 min post infusion)
- Inability to provide informed consent
- Age less than 18 or greater than 65 years
- Serum creatinine \> 1.8 mg/dL, In addition, there must be no change in serum creatinine of \> 0.4 mg/dl in the last 6 months.
- Baseline Hb \< 10.5 gm/dL in women, or \< 13 gm/dL in men
- Baseline LFT's outside of normal range with the exception of Gilberts Syndrome. n. Presence of gallstones (subjects may be eligible two weeks after a laparoscopic cholecystectomy ).
- o. Hemangioma in liver on baseline ultrasound exam
- p. Untreated proliferative retinopathy
- q. Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast feeding
- r. Evidence of sensitization as determined by a general PRA with reactivity \> 20%. t. Insulin requirement \> 0.7 IU/kg/day
- s. HbA1C \> 12%
- t. Inability to complete all scheduled visits during screening and post-transplant follow-up
- u. Hyperlipidemia (fasting LDL cholesterol \> 130 mg/dL, treated or untreated; and/or fasting triglycerides \> 200 mg/dL).
- v. Under treatment for a medical condition requiring chronic use of steroids at a dose \> prednisone 5 mg/day w. Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT INR \> 1.5 x. Addison's disease.y. EBV- negative subjects (use EBNA test for screening) to reduce potential risk of EBV infection for previously unexposed recipient.
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Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00288977
Start Date
September 1 2000
End Date
June 1 2008
Last Update
March 16 2017
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