prophylaxis against renal transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection
Conditions
Interventions
Trade Name: Ciclosporin Pro 25 mg Weichkapseln
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Male or female, aged >= 18 years 3. One or two renal transplants and at least 6 months post-transplantation 4. Maintenance treatment with Sandimmun® Optoral (with or without other immunosuppressive drugs), and regularly controlled by a transplantation centre 5. Stable individualised dose of ciclosporin and no change in immunosuppressive regimen for at least 2 months prior to study start 6. Stable graft function for at least 2 months and = 1 year, surgically sterilised, or women of childbearing potential must have a negative pregnancy test immediately prior to study entry, and meet the criteria for highly effective birth control with a low failure rate, i.e. less than 1% per year (e.g. implants, injectables, oral contraceptive steroids, intrauterine device, sexual abstinence, vasectomised partner). The investigator is responsible for determining whether the subject has adequate birth control for study participation. 8. Patient agrees to follow the study-specific instructions 9. Patient is able and willing (professional situation, family situation, planned holidays etc.) to come to the foreseen visits including four 13 hour-visits for the pharmacokinetic profiles 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. History of hypersensitivity to ciclosporin or any of the other excipients 2. Previous transplant with any organ other than kidney 3. Rejection episode within the past 6 months prior to the start of the study 4. Clinically relevant co-existing disease or other abnormal condition which may compromise function of gastrointestinal tract, kidney or liver or which could influence ciclosporin pharmacokinetic profiles 5. Active malignancy 6. Uncontrolled hypertension 7. Known or suspected significant hepatic impairment 8. Clinically significant hyperkalaemia (K+ > 6 mmol/l) 9. Clinically significant laboratory and/or physical changes during the last 2 months prior to the start of the study 10. Change in concomitant medication (drugs known to affect the pharmacokinetics of ciclosporin) during the past 2 months prior to study start 11. Any use of drug, prescribed or over-the-counter, (except stable concomitant medication) within 2 weeks prior to the first administration of study medication except this will not affect the outcome of the study in the opinion of the clinical investigator 12. Existing or intended pregnancy or breast feeding. 13. Any other condition of the patient that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s compliance or adherence to protocol requirements 14. Previous enrolment in this study or participation in any other drug investigational trial within the past 2 months (or five half-lives whatever is longer) prior to enrolment or simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To proof a lesser reduction of bioavailability due to high-fat nutrition of Ciclosporin Pro compared to Sandimmun® Optoral in patients with stable renal transplants;Secondary Objective: • To examine the nutrition effect on the bioavailability of Ciclosporin Pro • To examine the nutrition effect on the bioavailability of Sandimmun® Optoral • To examine the bioequivalence of Ciclosporin Pro versus Sandimmun® Optoral under fasting conditions • To examine the bioequivalence of Ciclosporin Pro versus Sandimmun® Optoral under fed conditions • To examine the safety and tolerability of Ciclosporin Pro versus Sandimmun® Optoral in patients with stable renal transplants ;Primary end point(s): The reduction of bioavailability due to high-fat food measured by the difference D of ln transformed bioavailability variables (AUCSS,t, CSS,max, and CSS,min) under high-fat conditions vs. under fasting conditions | — |
Countries
Germany
Outcome results
None listed