NCT00501709

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 6, 2020

Status Verified

April 1, 2020

Enrollment Period

9.8 years

First QC Date

July 12, 2007

Last Update Submit

April 30, 2020

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • lnsulin independence

    improved glycemic control

    monthly

Study Arms (1)

Treatment

EXPERIMENTAL

Allogenic pancreatic islet transplant using belatacept and raptiva

Drug: Belatacept and Raptiva

Interventions

Belatacept and RaptivaDRUG

immunosuppressant agent to prevent rejection in transplant recipients

Also known as: immunosuppressant
Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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%.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

AbataceptefalizumabImmunosuppressive Agents

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsImmunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 16, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 6, 2020

Record last verified: 2020-04

Locations

US(1)