simultaneous pancreas/kidney allograft transplantation MedDRA version: 16.1 Level: LLT Classification code 10048622 Term: Pancreatic transplant System Organ Class: 100000004865 MedDRA version: 16.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Certican
Product Name: Certican
Pharmaceutical Form: Tablet
Trade Name: Myfortic
Product Name: Myfortic
Pharmaceutical Form: Tablet
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¬-peptidenegative (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 (2 years). 3 Patient must have signed the Patient Informed Consent Form. 4 Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaver transplant, with either intestinal or bladder and either portal or XML File Identifier: jgXRtxN9yCiFR7cToieRD2u4L7Y= Page 11/21 systemic venous drainages. 5 Patients must have preserved sight at least on one eye with visual acuity of at least 5/60 eye 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 60 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 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. Pancreatic duct occlusion technique. 11. Donor is older than 65 years of age. 12. The use of any other commercial or investigational immunosuppressive drugs is prohibited if it is not clinically indicated. 13. Patient has an immunological high risk, defined as a PRA grade > 50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the evolution of advanced diabetic retinopathy between the 2 groups of Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation in terms of the prevalence of micro vascular retinal abnormalities (micro aneurysms, micro hemorrhages and hemorrhages), range retinal neovascularization and macular thickness at 1 and 2 years pot-transplant 2 a) To compare other parameters of diabetic retinopathy (visual acuity, intraocular bleeding, need for laser therapy and other) between the 2 groups b) To compare graft survival, rejection rate, treatment tolerance and the time to wound healing between the 2 groups;Secondary Objective: a) i. Change in visual acuity ii. need for laser therapy iii. new vessels formation within the field assessed by the color fundus stereoscopic photographs iv. new occurrence or change in cataract grading scale of more than 1 step v. changes in retinal thickness compared to baseline examination assessed by OCT. Changes will be compared in the whole group and separately in subjects with pre-transplant OCT signs of macular (central macular thickness of > 250 µm or more) vi. new occurrence of intravitreal bleeding registered by the patient and confirmed by the ophthalmologist vii. retinopathy level assessed using the methodology of the EURODIAB IDDM Complications Study [1] b) General parameters (patient and graft survival rates; rejection rate; treatment intolerance; the time to complete wound healing; blood glucose and C-peptide levels; creatinine clearance rate; glycosylated hemoglobin values);Primary end point(s): a) need for laser therapy except procedures that had been scheduled already pre-transplant and were performed not later than 4 months post-transplant b) newly diagnosed proliferative retinopathy that was not present on the pre-transplant examination c) newly diagnosed clinically significant macular edema d) worsening of visual acuity of more than 2 rows of Snellen´s optotypes e) o | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Ophthalmic parameters: i. Change in visual acuity ii. need for laser therapy except procedures that had been scheduled already pre-transplant and were performed not later than 4 months post-transplant iii. new vessels formation within the field assessed by the color fundus stereoscopic photographs (performed according to the EURODIAB IDDM XML File Identifier: jgXRtxN9yCiFR7cToieRD2u4L7Y= Page 12/21 Complications Study [1] ETDRS report number 10 [2] iv. new occurrence or change in cataract grading scale of more than 1 step v. changes in retinal thickness compared to baseline examination assessed by OCT. Changes will be compared in the whole group and separately in subjects with pre-transplant OCT signs of macular (central macular thickness of > 250 µm or more) vi. new occurrence of intravitreal bleeding registered by the patient and confirmed by the ophthalmologist vii. retinopathy level assessed using the methodology of the EURODIAB IDDM Complications Study [1] b) 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 97 criteria iii. treatment intolerance (permanent mycophenolic acid or everolimus withdrawal for more than 40 days iv. the time to complete wound healing as assessed by the surgeon as well as the transplant specialist and documented by photography v. blood glucose and C-peptide levels (AUC) following a mixed meal test vi. creatinine clearance rate calculated by the MDRD formula vii. glycosylated hemoglobin values;Timepoint(s) of evaluation of this end point: The study will last 2 years with a primary endpoint at 1 year and at the study end. Extension of the study duration for survival data may be decided by the Study board. Patients will be enrolled over a period of | — |
Countries
Czech Republic
Contacts
Public ContactIKEM
Institut klinické a experimentální medicíny
Outcome results
None listed