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Trial record 86 of 126 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

Islet Transplantation Using Abatacept

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ClinicalTrials.gov Identifier: NCT00276250
Recruitment Status : Completed
First Posted : January 13, 2006
Results First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Nicole Turgeon MD, Emory University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: Efalizumab
Drug: Abatacept
Drug: Belatacept

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Nine subjects signed informed consent. During evaluation, four participants were found ineligible for study inclusion. Five participants completed the evaluation process and were listed for an islet transplant

Reporting Groups
  Description
Efalizumab Followed by Abatacept Regimen Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
Abatacept Regimen Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
Belatacept Regimen Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.

Participant Flow:   Overall Study
    Efalizumab Followed by Abatacept Regimen   Abatacept Regimen   Belatacept Regimen
STARTED   4   1   0 
COMPLETED   4   1   0 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Efalizumab Followed by Abatacept Regimen Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
Abatacept Regimen Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
Belatacept Regimen Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
Total Total of all reporting groups

Baseline Measures
   Efalizumab Followed by Abatacept Regimen   Abatacept Regimen   Belatacept Regimen   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   1   0   5 
Age 
[Units: Participants]
       
<=18 years   0   0      0 
Between 18 and 65 years   4   1      5 
>=65 years   0   0      0 
Gender 
[Units: Participants]
       
Female   1   1      2 
Male   3   0      3 
Region of Enrollment 
[Units: Participants]
       
United States   4   1      5 


  Outcome Measures

1.  Primary:   The Number of Insulin-independent Subjects at Day 75 (± 5 Days) Following the First Islet Cell Transplantation   [ Time Frame: 75 days post-transplantation ]

2.  Secondary:   Number of Insulin-independent Subjects Following Islet Transplantation   [ Time Frame: 1, 3, 6, 9,12,18 and 24 months post-transplantation ]

3.  Secondary:   Number of Subjects With HbA1C Less Than 6.5%   [ Time Frame: 6 months post-transplantation ]

4.  Secondary:   Number of Subjects With HbA1C Levels < 6.5%   [ Time Frame: 12 months post-transplantation ]

5.  Secondary:   Number of Subjects With HbA1C < 6.5%   [ Time Frame: 24 months post-transplant ]

6.  Secondary:   Number of Subjects With HbA1C < 6.5%   [ Time Frame: 36 months post-transplantation ]

7.  Secondary:   Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels   [ Time Frame: 1, 3, 6, 9,12,18 and 24 months post-transplantation ]

8.  Secondary:   The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.   [ Time Frame: 1, 3, 6, 9,12,18 and 24 months post-transplantation ]

9.  Secondary:   Number of Subjects With Normal Renal Function, as Measured by Serum Creatinine Levels   [ Time Frame: 24 months after transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Enrollment in this study was limited by the removal of Efalizumab from the market in 2009 after patients (external to this study) being treated for plaque psoriasis were diagnosed with Progressive Multifocal Leukoencephalopathy (PML).


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nicole Turgeon, MD
Organization: Emory University
phone: 404-727-3257
e-mail: nturgeo@emory.edu



Responsible Party: Nicole Turgeon MD, Emory University
ClinicalTrials.gov Identifier: NCT00276250     History of Changes
Other Study ID Numbers: IRB00021852
1136-2005 ( Other Identifier: Emory University )
First Submitted: January 12, 2006
First Posted: January 13, 2006
Results First Submitted: April 25, 2016
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016