Kidney Transplantation
Conditions
Interventions
Trade Name: Prograf Capsules
Product Name: Prograf
Product Code: FK506
Pharmaceutical Form: Capsule*
Trade Name: Neoral
Product Name: Cyslospron A
Pharmaceutical Form: Capsule*
Sponsors
Medical University Vienna, Department of Medicine III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is recipient of a deceased or living donor renal transplant (including re-transplants) 2. Patient was =18 years of age at the time of transplantation. 3. Patient is at least 6 months post-transplant. 4. Patient is on a cyclosporine-based immunosuppression regimen in combination with/without MMF and/or steroids at study entry. 5. Patient has a functioning renal allograft and an estimated GFR =30 mL/min/1.73m2 within four weeks prior to study entry. 6. Patient has a stable graft function without biopsy proven acute rejection episode within 3 months prior to study entry. 7. Patient has not experienced a cardiovascular event (e.g. myocardial infarction, stroke, percutaneous angioplasty, bypass surgery,..) within 3 months prior to study entry. 8. Patient has been fully informed and has given written informed consent according to ICH-GCP. 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. 9. Females are not pregnant and agree to practice effective birth control while receiving immunosuppressant medication. 10. Patient has indications for conversion at the investigators discretion or is suffering from cyclosporine associated side effects like hypertension (=130 and/or =80 mm Hg, with or without antihypertensive therapy), hyperlipidemia (LDL-cholesterol = 100 mg/dl or triglycerides=200 mg/dl and non-HDL-cholesterol =130 mg/dl) or cosmetic side effects. 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. Patient is recipient of a solid organ transplant other than the kidney. 2. Patient has recurrence of primary renal disease, or de novo renal disease. 3. Patient is pregnant or lactating. 4. Patient had a known or suspected malignancy (except for treated squamous and basal cell skin cancers) <5 years before study entry or a history of post-transplant lymphoproliferative disease (PTLD). 5. Patient has known hypersensitivity to tacrolimus, or any of the recipients of the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change in EPC count in kidney graft recipients converted from cyclosporine to tacrolimus ;Secondary Objective: To evaluate the change in cystatin C as measure of renal function in kidney graft recipients converted from cyclosporine to tacrolimus To determine the effect of tacrolimus on humoral alloreactivity in long-term kidney graft recipients;Primary end point(s): The sample size calculation is based on the results of a pilot study of 90 stable kidney graft recipients, where the distribution of EPC counts was found to be strongly skewed to the right. Therefore, we used logarithmical transformation to normalize the distribution of the data. The mean lnEPC count was 3.6 ± 1.0 per high power field. Assuming an increase of 15% in lnEPC count after conversion from cyclosporine to tacrolimus (asimilar effect was observed for statin users versus non-users in our pilot study) that persists for at least 2 years, and using a 2:1 randomization, 41 patients are needed in the cyclosporine group, and 82 in the tacrolimus group (type I error 0.05, power 80%). Accounting for an annual rate of graft loss and death of 5%, and an annual rate of drop out related to further changes in the immunosuppressive protocol of 5%, 49 patients are needed for the cyclosporine group, and 99 patients are needed for the tacrolimus group. The paired t-test will be used to compare lnEPC between the treatment groups at 3, 12 and 24 months post-randomization. | — |
Countries
Austria
Outcome results
None listed