KIDNEY TRANSPLANTATION MedDRA version: 14.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Advagraf
Pharmaceutical Form: Capsule, hard
Trade Name: Advagraf
Pharmaceutical Form: Capsule, hard
Trade Name: CERTICAN
Product Name: CERTICAN
Pharmaceutical Form: Tablet
Trade Name: C
Sponsors
Policlinico A. Gemelli
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patient over 18 years of age. 2) Male or female cadaveric donor over 18 years of age. 3) Female patients of child bearing potential agree to maintain effective birth control practice during the study and 3 months thereafter. 4) Patient has end stage kidney disease and is a suitable candidate for primary single renal transplantation. 5) Patient is receiving kidney transplant, from a cadaveric (not HLA identical) compatible ABO blood type. 6) Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person. 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1) Positive cross-match 2) Patient has an immunological high risk, defined as a PRA grade >20% in the previous 6 months and/or having a previous renal allograft 3) Patient has significant liver disease, defined as having during the past 30 days contiuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor. (HBVAg+, HCVab+). 4) Patient has severe hypercholesterolemia (>350mg/dL, 9.1 mmol/dL) or severe Leucopenia (WBC 35, obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate in the two immunosuppressive regimens the composite endpoint including: incidence of clinical + BPAR acute rejection at month 12, graft survival at month 12, percentage of patients with creatinine 1.8 mg/ml at month 12. ;Timepoint(s) of evaluation of this end point: 12 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Acute rejection: Time to first acute rejection; overall frequency of clinical acute rejections episodes; incidence of biopsy-proven acute rejections; incidence of and time to first corticosteroid-resistant rejection; severity of biopsy-proven acute rejections (Banff ’97 criteria) - Patient and graft survival at month 12 - percentage of patients who resumed or never stopped steroids at month 12, - percentage of patients who were converted from the assigned therapy at month 12. - Renal function as assessed by calculated creatinine clearance (MDRD). - Renal function as assessed by Ioexol determination at month 6 and 12 (optional) - Incidence of adverse events at month 6 and 12 - Absolute change in serum lipids (cholesterol, HDL, triglycerides, statines use) at month 6 and 12 - Absolute change in blood pressure control (systolic BP, diastolic BP, number of antihypertensive medications) at month 6 and 12 - Absolute change in glucose metabolism (fasting glucose, glycosilated Hb, insuline or oral anti-diabetic use) at month 6 and 12 - Incidence of and time to delayed graft function - Incidence of creeping creatinine above 30% from the lowest post-transplant creatinine (nadir creatinine) - Composite failure index: BPAR + death + Gloss + lost to follow-up - number of daily pills taken by the patient at month 12 (number of medication pills the patient is receiving for his/her treatment including all the medications) - protocol renal allograft biopsy taken at time 0 and at month 12 - incidence of wound healing complications at month 6: superficial and deep wound infections, incisional hernia - incidence of lymphocele at month 6, defined as any fluid collection evidenced by ultrasound . - Pharmacokinetic AUC profiles of Advagraf and Everolimus obtained on days 7 and 14 (if possible) ;Timepoint(s) of evaluation of this end point: 12 MONTHS | — |
Countries
Italy
Contacts
Public ContactSurgery department
Policlinico Gemelli
Outcome results
None listed