NEWS HIGHLIGHTSMedia Articles Related to Simulect (Basiliximab)
Sleep Apnea Raises BP for Kidney Transplant Patients (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2009.11.19]
Sleep apnea is common among kidney transplant patients, and those with the sleep disorder have higher systolic blood pressure despite taking more antihypertensive medications, a new study found.
Kidney Transplant, Sleep Disorder May Add Up to Trouble (HealthDay)
Source: Y! Health News Search RSS Feed [2009.11.19]
HealthDay - THURSDAY, Nov. 19 (HealthDay News) -- Kidney transplant patients
with sleep apnea are at increased risk for high blood pressure, heart
disease and stroke, Hungarian researchers say.
ASN: No CVD Benefit for Folic Acid in Kidney Transplant (CME/CE)
Source: MedPage Today Nephrology [2009.11.03]
SAN DIEGO (MedPage Today) -- Lowering homocysteine levels with folic acid supplementation yielded no cardiovascular benefit for stable renal transplant recipients, a randomized trial showed.
Lupus Patients Who Receive Kidney Transplants Rarely Develop Lupus Nephritis
Source: Lupus News From Medical News Today [2009.11.02]
Individuals with a history of lupus who receive a kidney transplant rarely develop the serious inflammatory condition lupus nephritis in their new organ, according to a paper being presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, CA. The findings indicate that having lupus should not keep individuals from seeking a kidney transplant if they need one.
Kidney Transplant Survival Possibly Impacted By Race Of Donor
Source: Transplants / Organ Donations News From Medical News Today [2009.11.02]
The race of kidney donors may affect the survival rates of transplant recipients according to a study by Henry Ford Hospital. "We found that transplant between races had better outcomes than transplant across races," says Anita Patel, M.D., transplant nephrologist at Henry Ford Hospital Transplant Institute and lead author of the study.
Published Studies Related to Simulect (Basiliximab)
A randomized trial of basiliximab with three different patterns of cyclosporin A initiation in renal transplant from expanded criteria donors and at high risk of delayed graft function. [2009.01]
This study assays therapy with basiliximab and different patterns of cyclosporin A (CsA) initiation in renal transplant (RT) recipients from expanded criteria donors (ECD) and at high risk of delayed graft function (DGF). A multicentre six-month open-label randomized trial with three parallel groups treated with basiliximab plus steroids, mycophenolate mofetil and different patterns of CsA initiation: early within 24 h post-RT at 3 mg/kg/d (Group 1; n = 38), and at 5 mg/kg/d (Group 2; n = 40), or delayed after 7-10 d at 5 mg/kg/d (Group 3; n = 36).
Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids. [2008.11.15]
BACKGROUND: Basiliximab, a monoclonal CD25 antibody has proofed effective in reducing acute rejection episodes in adults in various immunosuppressive regimens. The effect of basiliximab in the pediatric population is controversial... CONCLUSIONS: Addition of basiliximab induction to a regimen of cyclosporine microemulsion, mycophenolate mofetil, and steroids resulted in a numerically lower but not significant incidence of biopsy-proven acute rejection versus placebo and excellent graft and patient survival at 1 year in pediatric renal transplant recipients. Whether this numerical difference is a true therapeutic benefit in view of the higher rate and severity of subclinical rejections in the basiliximab group in the protocol biopsy will be investigated in a long-term follow-up study.
Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. [2008.11.15]
BACKGROUND: The aim of this substudy within a prospective, multicenter, placebo-controlled trial was to assess the pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on comedication with mycophenolate mofetil (MMF)... CONCLUSIONS: The currently recommended basiliximab dose for pediatric patients, when used with cyclosporine microemulsion and corticosteroids, yielded adequate drug exposure in children and adolescents also under MMF comedication. The observation that about a quarter of BPARs occurred despite adequate IL2-R blockade suggests that another T-cell activation pathway independent of the IL-2/IL-2R pathway is operative, for example, the IL-15 signaling pathway.
Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab. [2007.03]
BACKGROUND: The lower limit of exposure to calcineurin inhibitors has not yet been established in de novo renal transplant patients receiving mycophenolic acid therapy with basiliximab... CONCLUSIONS: These results indicate that enteric-coated mycophenolate sodium with reduced-exposure cyclosporine, steroids and basiliximab induction has an excellent therapeutic effect and is safe in de novo kidney transplant recipients. Lower C2 targets than previously recommended, particularly early post-transplant, do not appear to be associated with compromised efficacy.
Rabbit antithymocyte globulin versus basiliximab in renal transplantation. [2006.11.09]
BACKGROUND: Induction therapy reduces the frequency of acute rejection and delayed graft function after transplantation. A rabbit antithymocyte polyclonal antibody or basiliximab, an interleukin-2 receptor monoclonal antibody, is most commonly used for induction... CONCLUSIONS: Among patients at high risk for acute rejection or delayed graft function who received a renal transplant from a deceased donor, induction therapy consisting of a 5-day course of antithymocyte globulin, as compared with basiliximab, reduced the incidence and severity of acute rejection but not the incidence of delayed graft function. Patient and graft survival were similar in the two groups. (ClinicalTrials.gov number, NCT00235300 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
Clinical Trials Related to Simulect (Basiliximab)
Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients [Completed]
Most high risk keratoplasties are currently performed under systemic immunosuppression.
Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile,
administered for around 6 months. Due to potentially severe adverse effects, new
immunosuppressive exerting less side effects would be desirable. Basiliximab is a
monoclonal, chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from
activated T-cells. This agent is known to specifically inhibit T-cell proliferation upon
intravenous application only twice following transplantation. Basiliximab has already been
demonstrated effective in kidney transplantation.
This investigation is a prospective, randomized clinical trial on orthotopic, high-risk
penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary
endpoint is graft rejection. Secondary endpoint is clear graft survival.
Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-Term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids [Active, not recruiting]
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney
transplantation is associated with renal dysfunction and hypertension. The study will
evaluate the safety and efficacy of replacing the calcineurin inhibitors by using
basiliximab at monthly doses.
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant [Recruiting]
Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant [Active, not recruiting]
The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction
therapy combined with standard triple immunosuppression therapy, in the prevention of acute
rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.
The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis [Not yet recruiting]
The objective of this trial is to assess if treatment with basiliximab allows subjects to
taper off other immunosuppressive drug regimens without causing an increase in their
uveitis.
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