ClinicalTrials.Veeva

Menu

Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

A

AZ-VUB

Status

Terminated

Conditions

Islet Transplantation
Type 1 Diabetes

Treatments

Drug: ATG-Sirolimus-Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00409461
G.0084.02
4-2001-434
GOA/2004/10
G.0375.00

Details and patient eligibility

About

Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients

Sex

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 1 insulin-dependent diabetic patients
  • C-peptide < 0.15 nmol/l (<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
  • diabetic nephropathy
  • hypoglycaemic unawareness

Exclusion criteria

  • smoker before transplantation
  • plasma creatinine > 2 mg/dl
  • albuminuria >1000 mg/24 hrs
  • abnormal liver function
  • history of thrombosis or pulmonary embolism
  • history of malignancy, tuberculosis or chronic viral hepatitis
  • history of any other serious illness which could be relevant for the protocol
  • HLA antibodies
  • EBV antibody negative
  • HIV 1 & 2 antibody positive

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems