SIROLIMUS VERSUS MYCOPHENOLATE MOFETIL IN SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANTATION TO EVALUATE THE RISK OF HERNIA

Conditions

End-stage kidney disease in Type 1 diabetes, SIROLIMUS VERSUS MYCOPHENOLATE MOFETIL IN SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANTATION TO EVALUATE THE RISK OF HERNIA

Brief summary

A new occurrence of an incisional hernia that is closely related to the transplantation procedure

Detailed description

A new occurrence of hernia in other localizations without relation to SPK surgery, A new occurrence of a lymphocele or other surgical complications (ureteral leak, bleeding, infection) whenever after transplantation, Patient and graft survival rates, 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, Treatment intolerance (permanent mycophenolate mofetil or sirolimus withdrawal for more than 40 days, 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, Creatinine clearance rate calculated by the CKD-EPI formula and glycosylated hemoglobin values, Progression of diabetic microangiopathic complication (retinopathy, neuropathy)

Related papers

No related papers found yet.

Interventions

DRUGRapamune 1 mg coated tablets

DRUGMYCOPHENOLATE MOFETIL

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
A new occurrence of an incisional hernia that is closely related to the transplantation procedure	—

Secondary

Measure	Time frame
A new occurrence of hernia in other localizations without relation to SPK surgery, A new occurrence of a lymphocele or other surgical complications (ureteral leak, bleeding, infection) whenever after transplantation, Patient and graft survival rates, 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, Treatment intolerance (permanent mycophenolate mofetil or sirolimus withdrawal for more than 40 days, 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, Creatinine clearance rate calculated by the CKD-EPI formula and glycosylated hemoglobin values, Progression of diabetic microangiopathic complication (retinopath	—

Measure

Time frame

A new occurrence of hernia in other localizations without relation to SPK surgery, A new occurrence of a lymphocele or other surgical complications (ureteral leak, bleeding, infection) whenever after transplantation, Patient and graft survival rates, 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, Treatment intolerance (permanent mycophenolate mofetil or sirolimus withdrawal for more than 40 days, 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, Creatinine clearance rate calculated by the CKD-EPI formula and glycosylated hemoglobin values, Progression of diabetic microangiopathic complication (retinopath

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Countries

Czechia

Outcome results

None listed