maintenance kidney transplantation MedDRA version: M15 Level: LLT Classification code 10023438
Conditions
Interventions
Trade Name: Certican 0.5 mg Tabletten
Product Name: Certican Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolismus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Con
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, aged >18 years 2. Maintenance renal transplant recipients at least 6 months and not more than 10 years post-transplantation 3. Patients with a serum creatinine /= 720 mg/d) 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 > 1000 mg/day at baseline 4. Patients with hypersensitivity to Certican®, Sandimmun® Optoral, Prograf®, 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 3 months of enrollment in this trial (baseline) 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 (see also chapter 8.2) 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: The primary objective of this trial is to show superiority of a CNI-free regimen with respect to renal function assessed by glomerular filtration rate (GFR) – Nankivell method – at Month 12 as compared to the standard CNI-based regimen in stable renal transplant patients.;Secondary Objective: Secondary: - To assess renal function by GFR – Cockcroft-Gault and MDRD 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 evolution of renal function between baseline and Month 12 (creatinine slope) - To assess safety and tolerability at Month 12 (according to safety parameters specified in chapter 7.5) - To assess changes in cardiovascular risk (according to Framingham Score) between baseline and Month 12 - To assess changes in proteinuria between baseline and Month 12 ;Primary end point(s): Renal function assessed by glomerular filtration rate (GFR) - Nankivell method -12 months after study begin | — |
Countries
Germany
Outcome results
None listed