Islet Transplantation in Type 1 Diabetic Recipients of Kidney Transplants

This study has been completed.
Sponsor:
Collaborator:
Joslin Diabetes Center
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00288977
First received: February 7, 2006
Last updated: October 22, 2008
Last verified: September 2006
  Purpose

Study hypothesis is that we can reproduce results of islet transplantation in type one diabetics in patients with a kidney transplant.


Condition Intervention Phase
Diabetes
Kidney Transplantation
Procedure: Islet Infusion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Islet Transplantation in Type 1 Diabetic Recipients of Renal Allografts, Using the Edmonton Protocol

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • independence from insulin injections with adequate control of blood glucose in subjects with Type 1 diabetes at one year post final transplant

Estimated Enrollment: 40
Study Start Date: September 2000
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. Reduced awareness of hypoglycemia,
  2. Metabolic lability/instability,
  3. Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by:

i) Retinopathy— ii) Nephropathy— or

iii) Neuropathy—

Exclusion Criteria:

  1. 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 (•
  2. 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.
  3. Psychiatric disorder making the subject not a suitable candidate for transplantation,
  4. History of non-adherence to prescribed regimens
  5. Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB)
  6. Any history of malignancy except squamous or basal skin cancer
  7. 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.)
  8. 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)
  9. Inability to provide informed consent
  10. Age less than 18 or greater than 65 years
  11. 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.
  12. Baseline Hb < 10.5 gm/dL in women, or < 13 gm/dL in men
  13. 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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00288977

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Joslin Diabetes Center
Investigators
Principal Investigator: Martha Pavlakis, MD Beth Israel Deaconess Medical Center, Joslin Diabetes Clinic
  More Information

No publications provided

Responsible Party: Martha Pavlakis, Md., BIDMC
ClinicalTrials.gov Identifier: NCT00288977     History of Changes
Other Study ID Numbers: 2001P.001702
Study First Received: February 7, 2006
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Diabetes
Islet Transplantation

ClinicalTrials.gov processed this record on October 20, 2014