Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients
Summary
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Intervention
Sirolimus, cyclosporine
Status
Completed
Source
Wyeth
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00428064
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:40:26-0400
Clinical Trials
The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the mos...
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on t...
Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on saf...
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for diffe...
PubMed Articles
Effect of cyclosporine, tacrolimus and sirolimus on cellular senescence in renal epithelial cells.
In transplantation medicine calcineurin inhibitors (CNI) still represent the backbone of immunosuppressive therapy. The nephrotoxic potential of the CNI Cyclosporine A (CsA) and Tacrolimus (FK506) is ...
This study aimed to analyze adult kidney transplant recipients (KTRs) for the risk of new-onset diabetes after transplantation (NODAT) associated with viral serologies and immunosuppression regimens [...
Tacrolimus (TAC) increases the risk of posttransplant diabetes (PTDM) as compared to cyclosporine A (CYC). The present 12-months, multi-center, investigator-driven, prospective, randomized study was d...
mTOR Inhibition and Kidney Diseases.
Mammalian or mechanistic target of rapamycin (mTOR) is a serine-threonine kinase that plays essential roles in cell growth, proliferation, metabolism, and survival. Increased activation of the mTOR pa...
Dose adjustment of immunosuppressants during co-administration of posaconazole: a systematic review.
The purpose of this retrospective study was to analyze the dose adjustment of immunosuppressants (cyclosporine, tacrolimus and sirolimus) for the patients with allogeneic hematopoietic stem cell and s...
Medical and Biotech [MESH] Definitions
Immunophilins
Members of a family of highly conserved proteins which are all cis-trans peptidyl-prolyl isomerases (PEPTIDYLPROLYL ISOMERASE). They bind the immunosuppressant drugs CYCLOSPORINE; TACROLIMUS and SIROLIMUS. They possess rotamase activity, which is inhibited by the immunosuppressant drugs that bind to them.
Cyclosporine
A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).
Delayed Graft Function
General dysfunction of an organ occurring immediately following its transplantation. The term most frequently refers to renal dysfunction following KIDNEY TRANSPLANTATION.
Sirolimus
A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.
Transplantation Conditioning
Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.
