Study Protocol: A Pilot Study to Determine the Safety and Efficacy of Induction-Therapy, De Novo MPA and Delayed mTOR-Inhibition in Liver Transplant Recipients with Impaired Renal Function. PATRON-Study
| Autor: | J. Rochon, Stefan A. Farkas, Andreas A. Schnitzbauer, Hans J. Schlitt, Johannes L. Sothmann, Aiman Obed, Martin Loss, Edward K. Geissler, Marcus N. Scherer |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: |
Nephrology
Graft Rejection medicine.medical_specialty medicine.medical_treatment Recombinant Fusion Proteins Urology 610 Medizin Pilot Projects Liver transplantation lcsh:RC870-923 Mycophenolic acid 03 medical and health sciences Impaired renal function Study Protocol Basiliximab 0302 clinical medicine Induction therapy Internal medicine medicine Humans Renal Insufficiency PI3K/AKT/mTOR pathway Immunosuppression Therapy Sirolimus ddc:610 business.industry Patient Selection Antibodies Monoclonal Immunosuppression Mycophenolic Acid lcsh:Diseases of the genitourinary system. Urology 3. Good health Surgery Liver Transplantation Treatment Outcome Research Design 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Drug Therapy Combination Steroids business Immunosuppressive Agents medicine.drug |
| Zdroj: | BMC Nephrology, Vol 11, Iss 1, p 24 (2010) BMC Nephrology |
| Popis: | Background Patients undergoing liver transplantation with preexisting renal dysfunction are prone to further renal impairment with the early postoperative use of Calcineurin-inhibitors. However, there is only little scientific evidence for the safety and efficacy of de novo CNI free "bottom-up" regimens in patients with impaired renal function undergoing liver transplantation. This is a single-center study pilot-study (PATRON07) investigating safety and efficacy of CNI-free, "bottom-up" immunosuppressive (IS) strategy in patients undergoing liver transplantation (LT) with renal impairment prior to LT. Methods/Design Patients older than 18 years with renal impairment at the time of liver transplantation eGFR < 50 ml/min and/or serum creatinine levels > 1.5 mg/dL will be included. Patients in will receive a CNI-free combination therapy (basiliximab, MMF, steroids and delayed Sirolimus). Primary endpoint is the incidence of steroid resistant acute rejection within the first 30 days after LT. The study is designed as prospective two-step trial requiring a maximum of 29 patients. In the first step, 9 patients will be included. If 8 or more patients show no signs of biopsy proven steroid resistant rejection, additional 20 patients will be included. If in the second step a total of 27 or more patients reach the primary endpoint the regimen is regarded to be safe and efficient. Discussion If a CNI-free-"bottom-up" IS strategy is safe and effective, this may be an innovative concept in contrast to classic top-down strategies that could improve the patient short and long-time renal function as well as overall complications and survival after LT. The results of PATRON07 may be the basis for a large multicenter RCT investigating the new "bottom-up" immunosuppressive strategy in patients with poor renal function prior to LT. http://www.clinicaltrials.gov-identifier: NCT00604357 |
| Databáze: | OpenAIRE |
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