Phase 2
Completed N=10
Calcineurin Inhibitor (CNI)-Free Immunosuppressive Regimen in T1D Patients Receiving Islet Transplantation
Source: ClinicalTrials.gov NCT01346085 ↗Enrolled (actual)
10
Serious AEs
80.0%
Results posted
May 2014
Primary outcomePrimary: The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion — 4 participants
Summary
Our final objective is to develop an adoptive therapy with tolerogenic donor-specific Tr1 cells in T1D patients undergoing pancreatic islet transplantation (Tx). The achievement of this objective depends by the availability of an immunosuppressive treatment (IS) compatible with the survival, function, and expansion of the transferred Tr1 cells. For this purpose the investigators design a CNI-free single-group, phase 1-2 trial excluding the ATG or anti-CD25 induction therapy after the 1st islet infusion
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion |
4 | — |
| SECONDARY Insulin Independence With Adequate Glycemic Control Throughout Follow-up |
4 | — |
| SECONDARY Glycated Hemoglobin Levels Throughout Follow-up |
— | — |
| SECONDARY Basal and Stimulated Blood C-peptide Levels in Response to Arginine Challenge Throughout Follow-up |
— | — |
| SECONDARY the Reduction in Insulin Requirement Compared to Baseline |
— | — |
| SECONDARY Severe Hypoglycemic Events Since Completion of Transplant |
— | — |
| SECONDARY Any Adverse Event Throughout Follow-up |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients aged 18-65yr
- ability to provide written informed consent and comply with the study protocol procedures
- clinical history of type 1 diabetes with onset 12%
- BMI >30 kg/m2, or insulin requirement of > 0.8 IU/kg/day;
- poorly controlled hypertension;
- untreated proliferative diabetic retinopathy;
- presence or history of macroalbuminuria (>300mg/g day) or measured glomerular filtration rate <60 ml/min/1.73 m2 for females and <70 ml/min/1.73 m2 for males
- for female participants: positive pregnancy test, presently breast-feeding, or unwilling to use effective contraceptive measures for the duration of the study and 3 months after discontinuation
- for male participants: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception;
- any history of malignancy within the previous 5 years, except for completely resected squamous or basal cell carcinoma of the skin;
Data sourced from ClinicalTrials.gov (NCT01346085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.