Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00501709
First received: July 12, 2007
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.


Condition Intervention Phase
Type 1 Diabetes
Drug: Belatacept
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • lnsulin independence [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2004
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Belatacept
    IV infusion - 10mg per kilo at day 0,4,14,28,56,84 and then 5mg per kilo monthly through month 12 and then 5mg per kilo every 4-6 weeks for the remainder of the study.
  Eligibility

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

Inclusion Criteria:

  • Type 1 Diabetes
  • Metabolic lability/instability characterized by hypoglycemia or ketoacidosis(>2 hospital admissions in the previous year), erratic glucose profiles(MAGE >120mg/dL), or disruption in lifestyle(danger to life, self or others). Reduced awareness of hypoglycemia or > 1 episode in the last 1.5 years of severe hypoglycemia.
  • Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of intensive management efforts with diabetes care team.
  • Progressive secondary complications as defined by

    • a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or
    • urinary albumin excretion rate >300mg/day but proteinuria <3g/day; or
    • symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)

Exclusion Criteria:

  • Patient weighs more than 80kg or body mass index BMI>28
  • Patient's insulin requirement is >55 Units/day.
  • Current use of immunosuppressive agents.
  • History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin).
  • Active peptic ulcer disease.
  • Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications.
  • Untreated proliferative retinopathy.
  • Pregnancy or breastfeeding.
  • Female subjects not post-menopausal or surgically sterile, or not using an acceptable method or contraception.
  • Active infections.
  • Major ongoing psychiatric illness.
  • Ongoing substance abuse, drug or alcohol; or recent history of noncompliance.
  • Portal hypertension or history of significant liver disease.
  • Lymphopenia (<1000/ul) or leukopenia (<3000 total leukocytes/ul) or an absolute CD4 count <500/ul.
  • Presence or history of panel-reactive anti-HLA antibody >20%.
  • Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM).
  • Serologic evidence of infection with HIV or HbsAg or HCV Ab positive.
  • Creatinine clearance <60ml/min/m2.
  • Positive lymphocytoxic cross-match using donor lymphocytes and serum
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501709

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Peter G Stock, M.D., Ph.D. University of California, San Francisco
Principal Investigator: Andrew Posselt, M.D., Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00501709     History of Changes
Other Study ID Numbers: 39-42C
Study First Received: July 12, 2007
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014