Surgical complications (hernia) after simultaneous pancreas and kidney transplantation
Conditions
Interventions
Trade Name: Rapamune
Pharmaceutical Form: Tablet
INN or Proposed INN: SIROLIMUS
CAS Number: 53123-88-9
Current Sponsor code: Rapamune
Other descriptive name: Rapamune
Concentration unit: mg milligram(
Sponsors
Institut klinické a experimentální medicíny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Male or female patients, of 18 to 65 years of age, with a pre- or an end-stage renal failure, Type 1-diabetic nephropathy, C¬-peptide-negative (defined as C-peptide upper limit 0.2 nmol/l . If C-peptide is > 0.1 nmol/l, mixed-meal test will be performed with C-peptide upper limit > 0.2 nmol/l). 2 Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years). 3 Patient must have signed the Patient Informed Consent Form. 4 Patient is scheduled to be put on waiting-list for a primary simultaneous pancreas/kidney (SPK) cadaver transplant, with either intestinal or bladder and either portal or systemic venous drainages. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant or breastfeeding. 2. Patient is allergic or intolerant to any drug comprising both immunosuppressive protocols 3. Patient has a positive T-cell cross-match on the most recent serum specimen. 4. Patient is known for active liver disease or has significant liver disease; defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal. 5. Patient has history of an established prothrombotic disorders. 6. Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence. 7. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomization. 8. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication. 9. Patient receives a kidney transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone. 10. Donor is older than 65 years of age. 11. The use of any other commercial or investigational immunosuppressive drugs is prohibited if it is not clinically indicated. 12. Patient has a high immunological risk, defined as a PRA grade > 50% 13. Patient has a history of an extensive abdominal operation or a hernia in the abdominal wall
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The incidence of incisional hernia in patients after simultaneous pancreas and kidney transplantation treated by sirolimus versus mycophenolate mofetil - To compare the evolution of incisional hernia requiring surgery at 1, 2 and 3 years post-transplant;Secondary Objective: To compare other clinical parameters - graft survival, rejection rate, treatment tolerance, kidney and pancreas graft function and other parameters between the 2 groups ;Primary end point(s): A new occurrence of an incisional hernia that is closely related to the transplantation procedure. Hypothesis: There is no higher incidence of incisional hernia in sirolimus group compared to mycophenolate mofetil treated subjects ;Timepoint(s) of evaluation of this end point: 1, 2 and 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Surgical complications a) A new occurrence of hernia in other localizations without relation to SPK surgery b) A new occurrence of a lymphocele or other surgical complications (ureteral leak, bleeding, infection) whenever after transplantation General parameters i. Patient and graft survival rates ii. Rejection rate (kidney, pancreas or both). A kidney or pancreas biopsy will be taken as clinically indicated in case of suspected rejection of either kidney or pancreas. Biopsy analysis will be done according to latest BANFF 2017 criteria iii. Treatment intolerance (permanent mycophenolate mofetil or sirolimus withdrawal for more than 40 days iv. blood glucose and C-peptide levels (AUC) following a mixed meal test, average levels; blood glucose variability assessed a standard error of glucose levels registered using continuous glucose monitoring (CGM) with a subcutaneous glucose sensor v. creatinine clearance rate calculated by the CKD-EPI formula and glycosylated hemoglobin values ;Timepoint(s) of evaluation of this end point: 1, 2, 4, 12, 24 and 36 months after transplantation | — |
Countries
Czech Republic
Contacts
Public ContactKlinika diabetologie
Institut klinické a experimentální medicíny
Outcome results
None listed