Pre Transplant Rapamycin Treatment in Islet Transplantation Alone (ITA-Rp)
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Purpose
Numerous changes to the original Edmonton protocol have been proposed in the attempt of improving the still unsatisfactory long-term function of ITA. Rapamycin may blunt the early inflammatory response to islet transplantation in the liver, thus favoring islet engraftment.
Aim of the investigators study was to evaluate the effect of a pre-transplant treatment with rapamycin in patients with type 1 diabetes receiving islet transplant alone and immunosuppression according to the Edmonton protocol.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Drug: rapamycin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Pre-transplant Rapamycin Treatment and Tacrolimus Levels on the Outcome of Islet Transplantation Alone in Patients Receiving Edmonton Protocol. |
- Evidence of insulin independence with adequate control of blood glucose (<140 mg/mL fasting; < 180 mg/mL post prandial, after the final infusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- basal and stimulated C-peptide levels [ Time Frame: weekly within 1st month; monthly for 1 year ] [ Designated as safety issue: No ]
- glycated haemoglobin [ Time Frame: monthly ] [ Designated as safety issue: No ]
- rapamycin and tacrolimus trough levels [ Time Frame: every week for the first month, and monthly thereafter ] [ Designated as safety issue: Yes ]
- renal and liver function, white blood cells count, total lymphocytes and lymphocytes subpopulations (CD24, CD19), hemoglobin, fibrinogen (FG), cross-linked fibrin degradation products, C-reactive protein (CRP) [ Time Frame: every week for the first month, and monthly thereafter ] [ Designated as safety issue: Yes ]
| Enrollment: | 11 |
| Study Start Date: | October 2001 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rapamycin pre transplant
Pre-transplant rapamycin is administered for at least four weeks prior to the first islet infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/mL).
|
Drug: rapamycin
Pre-transplant rapamycin is administered for at least four weeks prior to the first islet infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/mL).
Other Name: Rapamune
|
Detailed Description:
Pre-transplant rapamycin is administered for at least four weeks prior to the first islet infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/mL). During the pre-transplant rapamycin treatment rapamycin trough levels, renal and liver function, white blood cells count, total lymphocytes and lymphocytes subpopulations, hemoglobin, fibrinogen, cross-linked fibrin degradation products, C-reactive protein, exogenous insulin requirement every week for the first month, and monthly thereafter are measured. Induction and maintenance immunosuppressive regimen after each islet infusion is administered according to the Edmonton protocol (daclizumab, rapamycin, target trough levels: 12-15 ng/mL during the first 3 months and 10-12 ng/mL thereafter and tacrolimus 2 mg/day,target trough levels: 4-6 ng/mL). Islets are infused into the liver through the portal vein under local anesthesia Portography is performed before and after infusion. The islet function is evaluated measuring fasting C-pep, EIR, and HbA1c, immediately before the first islet infusion and subsequently every day for the first week, and then weekly for the first month ; every month after the last islet infusion for the first year and every 6 month thereafter.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- type 1 diabetes
- ≥5 years of type 1 diabetes
- hypoglycaemia unawareness
- progression of chronic complications of diabetes despite intensive insulin regimen
Exclusion Criteria:
- overt kidney disease
- chronic liver disease
- hepatic haemangioma
- severe cardiomyopathy
- untreated coronary artery disease
Contacts and Locations| Italy | |
| Transplant Unit, IRCCS San Raffaele | |
| Milano, Italy, 20131 | |
| Principal Investigator: | Antonio Secchi, MD | Transplant Unit, IRCCS San Raffaele |
More Information
No publications provided by IRCCS San Raffaele
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Antonio Secchi, IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT01060605 History of Changes |
| Other Study ID Numbers: | emendament 2001 to C99B901251 |
| Study First Received: | February 1, 2010 |
| Last Updated: | February 1, 2010 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by IRCCS San Raffaele:
|
islet transplantation insulin independence C-peptide secretion |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Sirolimus Everolimus Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 13, 2013