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Pre Transplant Rapamycin Treatment in Islet Transplantation Alone

NCT01060605 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2010-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

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).

Sponsors & Collaborators

  • Ministry of Education, Universities and Research, Italy

    collaborator OTHER

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Telethon-JDRF Center for Beta cell replacement: clinical core.

    collaborator UNKNOWN

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Antonio Secchi, MD · Transplant Unit, IRCCS San Raffaele

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2005-12-31
Completion
2009-09-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060605 on ClinicalTrials.gov