Kidney Transplantation
Conditions
Keywords
renal transplantation, immunosuppression, prevention of acute rejection
Brief summary
To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation
Detailed description
Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.
Interventions
DRUGSirolimus
Sponsors
Proverum GmbH
KKS Netzwerk
Fujisawa GmbH
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* first kidney transplantation * re-transplantation * non-related living donor transplantation * patients \> 18 years * patients have given their written consent after being informed * female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test
Exclusion criteria
* related living donation * patients with known HIV-anamnesis * patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection * patients with present malignant disease * patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer * patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority * other reasons which depend on the assessment of the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - time to first biopsy proven acute rejection episode at month 12 | — |
| - graft failure at month 12 | — |
| - discontinuation of study medication at month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| - patient and graft survival at month 12 | — |
| - incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12 | — |
| - Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance) | — |
| - incidence and severity of infections at month 12 | — |
| - incidence of adverse events at month 12 | — |
Countries
Germany
Outcome results
None listed