Status:
COMPLETED
Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Islet Transplantation in Diabetes Mellitus Type 1
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The objective of this clinical trial was: \- to assess whether Reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in...
Detailed Description
Pancreatic islet transplantation has become a feasible option in the treatment of T1D which offers advantages over whole pancreas transplantation. Several strategies are being evaluated, including an...
Eligibility Criteria
Inclusion
- Ages 18-70 years, inclusive.
- Patients eligible for a pancreatic islet transplantation program
- Planned intrahepatic islet transplantation alone from a non-living donor with brain death.
- Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
- Patients who have 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
- Recipients of any previous transplant, including recipients of previous pancreatic islet transplantation.
- Recipients of islet from a non-heart beating donor.
- Pre-transplant average daily insulin requirement \>1 IU/kg/day.
- Pre-transplant (the more recent value obtained within the 4 months prior to enrolment) HbA1c \>11%.
- Patients with inadequate renal reserve as per calculated creatinine clearance (CLcr) \< 60 mL/min according to the Cockcroft-Gault formula (1976).
- Patients with hepatic dysfunction as defined by increased ALT (alanine aminotranferase) / AST (aspartate aminotransferase) \> 3 x upper limit of normal (ULN) and increased total bilirubin \> 3mg/dL \[\>51.3 µmol/L\]).
- 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 12 weeks of enrolment, including "anti-inflammatory" strategies (e.g. anti-TNFα, anti-IL-1 RA).
- Hypersensitivity to:
- ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID).
- 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).
- Additional exclusion criteria specific for US centre.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01817959
Start Date
October 1 2012
End Date
December 1 2017
Last Update
January 3 2024
Active Locations (9)
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1
The University of Chicago Medical Center, Department of Surgery, Division of Abdominal Organ Transplantation
Chicago, Illinois, United States, 60637
2
Institute for Clinical and Experimental Medicine (IKEM), Diabetes Centre; Department of Diabetes.
Prague, Czechia, 14021
3
Dipartimento di Medicina Interna e Specialistica; IRCCS Ospedale San Raffaele
Milan, Italy, 20132
4
S.S.D. Diabetologia, Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Piazza Ospedale Maggiore 3
Milan, Italy, 20162