This study is designed to assess whether a conversion from a CNI-based therapy to a CNI-free therapy with Certican® and Myfortic® in renal transplant patients with Chronic Allograft Nephropathy (CAN) is able to improve renal function. The study is investigating the efficacy of a conversion from a CNI-based to a CNI-free therapy and should show that this switch is safe and well tolerated. MedDRA version: 12.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Interventions
Trade Name: Certican Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration
Sponsors
Kliniken der Stadt Koeln gGmbH, Klinikum Merheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, aged >18 years 2. Renal transplant recipients suffering from Chronic Allograft Nephropathy (CAN) defined as having a statistically evident decrease in the GFR-slope at least 6 months prior to baseline. GFR-slope is calculated for the period from the day of TX until baseline (at least 6 months post transplantation) or at least 6 months before baseline and must have a significant negative slope as calculated by described statistic method (chapter 10.4.2). At least 5 GFR-values have to be present for slope-calculation. A renal biopsy at Baseline Visit will be performed to confirm the presence of CAN. This renal bisopsy may be taken within three months before Baseline visit 3. Allowed time interval between renal transplantation and Baseline Visit is = 6 months 4. Patients receiving Myfortic® / MMF and a CNI (Sandimmun® Optoral or Prograf®) with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month before baseline 5. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility (see also chapter 8.2) 6. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than one previous renal transplantation 2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney 3. Patient with proteinuria > 1g/day total Protein in Urine or > 500mg/day Albumin in Urine at baseline 4. Patients with hypersensitivity to Certican®, mycophenolic acid, or other components of the formulation (e.g. lactose; see also SPCs) 5. Patients who have received an investigational drug within four weeks prior to baseline 6. Patients who suffered from severe rejection (more than or equal to BANFF II acute rejection), recurrent acute rejection, or steroid resistant rejection within 6 months of enrollment in this trial (baseline). A renal biopsy at Baseline Visit will be performed to exclude any signs of rejection. This renal biopsy may taken within 3 month before Baseline visit 7. Patients with thrombocytopenia (platelets 3 times UNL) 13. Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating and/or who are unwilling to use effective means of contraception 14. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study 15. Evidence of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess improvement of renal function of kidney allograft recipients suffering from a chronic allograft nephropathy (CAN) after therapy switch to a CNI-free regimen between Baseline and Month 12 by monitoring the GFR slope using Cockcroft-Gault method ;Secondary Objective: To assess improvement of renal function assessed as glomerular filtration rate (GFR) – Nankivell method – at Month 12 To assess each efficacy variable (time to biopsy proven acute rejection, graft loss, death) at Month 12 To assess occurrence of treatment failures up to or at Month 12, while treatment failure is defined as a composite endpoint of biopsy proven acute rejection, graft loss, death, loss to follow up and discontinuations due to lack of efficacy or toxicity or conversion to another regimen (at least one condition must be present) To assess safety and tolerability during the trial and finally at Month 12 To assess changes in proteinuria between BL and Month 12 Cardiovascular risk factors (blood pressure, cholesterol (HDL, LDL), triglyceride, documentation of antihypertensive drugs) ;Primary end point(s): Improvement of renal function between Baseline and Month 12 by monitoring the GFR slope using Cockcroft-Gault method | — |
Countries
Germany
Outcome results
None listed