NCT01060605

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

4.2 years

First QC Date

February 1, 2010

Last Update Submit

February 1, 2010

Conditions

Diabetes Mellitus, Type 1

Keywords

islet transplantationinsulin independenceC-peptide secretion

Outcome Measures

Primary Outcomes (1)

  • Evidence of insulin independence with adequate control of blood glucose (<140 mg/mL fasting; < 180 mg/mL post prandial, after the final infusion

    1 year

Secondary Outcomes (4)

  • basal and stimulated C-peptide levels

    weekly within 1st month; monthly for 1 year

  • glycated haemoglobin

    monthly

  • rapamycin and tacrolimus trough levels

    every week for the first month, and monthly thereafter

  • 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)

    every week for the first month, and monthly thereafter

Study Arms (1)

Rapamycin pre transplant

EXPERIMENTAL

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

Interventions

rapamycinDRUG

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).

Also known as: Rapamune
Rapamycin pre transplant

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 1 diabetes
  • ≥5 years of type 1 diabetes
  • hypoglycaemia unawareness
  • progression of chronic complications of diabetes despite intensive insulin regimen

You may not qualify if:

  • overt kidney disease
  • chronic liver disease
  • hepatic haemangioma
  • severe cardiomyopathy
  • untreated coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transplant Unit, IRCCS San Raffaele

Milan, 20131, Italy

Location

Related Publications (2)

  • Benedini S, Ermetici F, Briganti S, Codella R, Terruzzi I, Maffi P, Caldara R, Secchi A, Nano R, Piemonti L, Alejandro R, Ricordi C, Luzi L. Insulin-mimetic effects of short-term rapamycin in type 1 diabetic patients prior to islet transplantation. Acta Diabetol. 2018 Jul;55(7):715-722. doi: 10.1007/s00592-018-1141-z. Epub 2018 Apr 13.

    PMID: 29654388DERIVED

  • Piemonti L, Maffi P, Monti L, Lampasona V, Perseghin G, Magistretti P, Secchi A, Bonifacio E. Beta cell function during rapamycin monotherapy in long-term type 1 diabetes. Diabetologia. 2011 Feb;54(2):433-9. doi: 10.1007/s00125-010-1959-6. Epub 2010 Nov 3.

    PMID: 21046356DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Antonio Secchi, MD

    Transplant Unit, IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 2, 2010

Study Start

October 1, 2001

Primary Completion

December 1, 2005

Study Completion

September 1, 2009

Last Updated

February 2, 2010

Record last verified: 2010-01

Locations

IT(1)