| Trial ID: | L6159 |
| Source ID: | NCT01346085
|
| Associated Drug: |
Cni Free Immunosuppression
|
| Title: |
Calcineurin Inhibitor (CNI)-Free Immunosuppressive Regimen in T1D Patients Receiving Islet Transplantation
|
| Acronym: |
ECIT-1
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01346085/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: CNI free immunosuppression
|
| Outcome Measures: |
Primary: The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion, Insulin independence is defined as no need for exogenous insulin, with adequate glycemic control \[i.e., glycated hemoglobin \<7% (normal range 3.5 - 6.0%), fasting glucose levels not exceeding 140 mg/dL (7.8 mmol/L) more than three times per week and 2-hour postprandial levels not exceeding 180 mg/dL (10 mmol/L) more than four times per week\]., 3 year | Secondary: Insulin Independence With Adequate Glycemic Control Throughout Follow-up, up to 3 years|Glycated Hemoglobin Levels Throughout Follow-up, up to 3 years|Basal and Stimulated Blood C-peptide Levels in Response to Arginine Challenge Throughout Follow-up, up to 3 year|the Reduction in Insulin Requirement Compared to Baseline, up to 3 years|Severe Hypoglycemic Events Since Completion of Transplant, up to 3 years|Any Adverse Event Throughout Follow-up, Among study participants there were no reports of death, post-transplantation lymphoproliferative disease, cancer, or opportunistic infections. There was no evidence of cytomegalovirus disease, infection or serological activation (CMV early antigens negative during the whole follow-up), nor of Epstein-Barr clinical and serological reactivation (all patients were antibodies anti EBV positive before transplant, as per the inclusion criteria)., up to 3 years
|
| Sponsor/Collaborators: |
Sponsor: Ospedale San Raffaele | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-10
|
| Completion Date: |
2012-06
|
| Results First Posted: |
2014-05-09
|
| Last Update Posted: |
2014-05-09
|
| Locations: |
IRCCS San Raffaele Scientific Institute, Milan, 20132, Italy|Universitè de Geneve, Geneve, 1211, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT01346085
|
