Calcineurin Inhibitor (CNI)-Free Immunosuppressive Regimen in T1D Patients Receiving Islet Transplantation (ECIT-1)

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Piemonti Lorenzo, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT01346085
First received: April 29, 2011
Last updated: April 9, 2014
Last verified: April 2014
Results First Received: April 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Intervention: Drug: CNI free immunosuppression

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CNI-free Single-group CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).

Participant Flow:   Overall Study
    CNI-free Single-group  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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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
CNI-free Single-group CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).

Baseline Measures
    CNI-free Single-group  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean ± Standard Deviation
  39.6  ± 4.94  
Gender  
[units: participants]
 
Female     6  
Male     4  
Region of Enrollment  
[units: participants]
 
Italy     8  
Switzerland     2  



  Outcome Measures
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1.  Primary:   The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion   [ Time Frame: 3 year ]

2.  Secondary:   Insulin Independence With Adequate Glycemic Control Throughout Follow-up   [ Time Frame: up to 3 years ]

3.  Secondary:   Glycated Hemoglobin Levels Throughout Follow-up   [ Time Frame: up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Basal and Stimulated Blood C-peptide Levels in Response to Arginine Challenge Throughout Follow-up   [ Time Frame: up to 3 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   the Reduction in Insulin Requirement Compared to Baseline   [ Time Frame: up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Severe Hypoglycemic Events Since Completion of Transplant   [ Time Frame: up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Any Adverse Event Throughout Follow-up   [ Time Frame: up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Lorenzo Piemonti
Organization: Ospedale San Raffaele
phone: +390226432706
e-mail: piemonti.lorenzo@hsr.it


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Piemonti Lorenzo, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT01346085     History of Changes
Other Study ID Numbers: ECIT-1
Study First Received: April 29, 2011
Results First Received: April 9, 2014
Last Updated: April 9, 2014
Health Authority: Italy: Ministry of Health