Status:
COMPLETED
Reparixin in Pancreatic Islet Transplantation
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Pancreatic Islet Transplantation in Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Inhibition of CXCL8 activity might represent a relevant therapeutic target to prevent injury occurring after pancreatic islet transplantation. Reparixin is a novel and specific inhibitor of CXCL8. Thi...
Detailed Description
Pancreatic islet transplantation has become a feasible option in the treatment of T1D which offers advantages over whole pancreas transplantation. However to date insulin independence can be obtained ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Ages 18-65 years, inclusive.
- Patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. This includes at least: a)clinical history compatible with T1D with insulin-dependence for \>5 years; b) undetectable stimulated (arginine or MMTT) C-peptide levels (\<0.3 ng/mL) in the 12 months before transplant. Sites will comply with any additional or more stringent criteria locally accepted, as per centre practice.
- Patients with adequate renal reserve as per calculated creatinine clearance (CLcr) \> 60 mL/min according to the Cockcroft-Gault formula (1976).
- Planned intrahepatic islet transplantation alone from a non-living donor with brain death.
- Planned infusion of 4000 to 7000 islet equivalent (IEQ)/kg body weight.
- Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
- Patients given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Exclusion criteria:
- Recipients of any previous transplant, except from recipients of a previous pancreatic islet transplantation that has failed, are off immunosuppression since at least 1 year and have negative anti-HLA.
- Recipients of islet from a non-heart beating donor.
- A body mass index \>30 kg/m2 or patient weight \<45 kg.
- Pre-transplant average daily insulin requirement \>1 IU/kg/day.
- Pre-transplant HbA1c \>11%.
- Patients with hepatic dysfunction as defined by increased ALT/AST \> 3 x ULN and increased total bilirubin \> 3mg/dL \[\>51.3 micromol/L\]).
- Patients who receive treatment for a medical condition requiring chronic use of systemic steroids.
- Treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant.
- Use of any investigational agent within 4 weeks of enrolment.
- Hypersensitivity to:
- ibuprofen or to more than one non steroidal anti-inflammatory drug
- medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib.
- Pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males).
- Sites will comply with any additional exclusion criteria locally accepted, as per centre practice.
Exclusion
Key Trial Info
Start Date :
July 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01220856
Start Date
July 28 2010
End Date
April 30 2013
Last Update
March 11 2021
Active Locations (2)
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1
University Hospital Carl Gustav Carus Dresden
Dresden, Germany, 01307
2
Ospedale San Raffaele
Milan, Italy, 20132