SIROLIMUS for End-stage kidney disease | Type 1 diabetes

Inclusion criteria

• {"criterion_text":"- 1\tMale or female patients, of 18 to 65 years of age, with a pre- or an end-stage renal failure, Type 1-diabetic nephropathy\n- Patient is scheduled to be put on waiting-list for a primary simultaneous pancreas/kidney (SPK) cadaver transplant"}

Exclusion criteria

• {"criterion_text":"- Patient is pregnant or breastfeeding\n- Patient has a history of an extensive abdominal operation or a hernia in the abdominal wall\n- Patient is allergic or intolerant to any drug comprising both immunosuppressive protocols\n- Patient has a positive T-cell cross-match on the most recent serum specimen\n- 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\n- Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence.\n- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication\n- Patient receives a kidney transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone\n- Donor is older than 65 years of age\n- Patient has a high immunological risk, defined as a PRA grade > 50%"}

Primary endpoints

• {"endpoint_text":"- A new occurrence of an incisional hernia that is closely related to the transplantation procedure","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- A new occurrence of hernia in other localizations without relation to SPK surgery","definition_or_measurement_approach":""}
• {"endpoint_text":"- A new occurrence of a lymphocele or other surgical complications (ureteral leak, bleeding, infection) whenever after transplantation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Patient and graft survival rates","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Biopsy taken as clinically indicated; biopsy analysis according to BANFF 2017 criteria"}
• {"endpoint_text":"- Treatment intolerance (permanent mycophenolate mofetil or sirolimus withdrawal for more than 40 days","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Blood glucose and C-peptide AUC following mixed meal test; glucose variability assessed by CGM (subcutaneous glucose sensor), reported as standard error of glucose levels"}
• {"endpoint_text":"- Creatinine clearance rate calculated by the CKD-EPI formula and glycosylated hemoglobin values","definition_or_measurement_approach":"Creatinine clearance calculated by CKD-EPI formula; measurement of HbA1c"}
• {"endpoint_text":"- Progression of diabetic microangiopathic complication (retinopathy, neuropathy)","definition_or_measurement_approach":""}

Czechia

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

18

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Institute For Clinical And Experimental Medicine

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia

Third parties

• {"country":"Czechia","full_name":"Institute for Clinical and Experimental Medicine","duties_or_roles":"Source of monetary support","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Czechia","full_name":"Ministry of Health of the Czech Republic, Czech Health Research Council","duties_or_roles":"Source of monetary support","organisation_type":""}