Industry-Sponsored Clinical Research Experience
Fujisawa USA, Inc., Protocol #20-96-003. A Randomized, Comparative Trial of Prograf (Tacrolimus, FK506) in Combination with Azathioprine or Mycophenolate Mofetil (MMF) vs. Neoral (Cyclosporine) with Mycophenolate Mofetil after Cadaveric Kidney Transplantation.
12/4/96-12/3/00. Site Principal Investigator: Scandling, JD.
Wyeth-Ayerst Research, Protocol #0468H1-309-US. A Comparative Study of the Effect and Equivalence of Sirolimus Oral Liquid versus Sirolimus Tablets, Administered with Cyclosporine and Corticosteroids in Renal Allograft Recipients.
1/15/98-12/31/99. Site Principal Investigator: Scandling, JD.
Wyeth-Ayerst Research, Protocol #0468E1-301-US. A Double-Blind, Comparative Study of the Effect of Two Dose Levels of Sirolimus Versus Azathioprine, Administered Concomitantly with Standard Immunosuppressive Therapy in Renal Allograft Recipients.
8/23/96-1/31/00. Site Principal Investigator: Scandling, JD.
Fujisawa USA, Inc., Protocol #20-97-002. A Randomized, Comparative Trial of the Effect of Antilymphocyte Induction on Tacrolimus plus Mycophenolate Mofetil Maintenance Immunosuppression after Simultaneous Kidney/Pancreas Transplantation.
3/15/98-12/31/03. Site Principal Investigator: Alfrey, EJ, then Scandling, JD.
Abbott Laboratories, Protocol #M97-761. A Pharmacokinetic and Safety, Open Label, Conversion Study of Abbott Cyclosporine and Neoral in Stable Six-Month Post-Renal Allograft Recipients.
3/25/98-3/24/99. Site Principal Investigator: Scandling, JD.
Abbott Laboratories, Protocol #M97-813. A Clinical Experience with Abbott Cyclosporine in De Novo Renal Transplant Subjects.
3/5/99-9/4/2000. Site Principal Investigator: Scandling, JD.
A Clinical Experience with Abbott Cyclosporine in De Novo Renal Transplant Patients (Extension). (Abbott M97-813E)
Wyeth-Ayerst Research, Protocol #0468E1-306-US. An Open-Label Extension of the Safety of Long-Term Administration of Sirolimus (Rapamune) in Solid Organ Transplant Recipients.
5/1/99-4/30/03. Site Principal Investigator: Scandling, JD.
Fujisawa USA, Inc., Protocol #20-98-002. Prograf (tacrolimus) as Secondary Intervention vs. continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure.
2/10/99-6/30/2005. Site Principal Investigator: Scandling, JD.
Roche Pharmaceuticals, Protocol #PV16000. A Randomized, Double-Blind, Double-Dummy, Active-Comparator Controlled Multi-Center Study of the Efficacy and Safety of Valganciclovir (Ro107-9070) vs. Oral Ganciclovir for Prevention of Cytomegalovirus Disease.
4/13/00-11/30/02. Site Principal Investigator: Scandling, JD.
Fujisawa USA, Inc., Protocol #20-00-002. A Randomized, Multicenter Comparative Trial of Prograf (Tacrolimus) in Combination with Rapamune (Rapamycin, Sirolimus) or CellCept (Mycophenolate Mofetil, MMF) after Kidney Transplantation.
7/14/00-6/30/02. Site Principal Investigator: Scandling, JD.
Protocol Blood Group A Subtyping in Renal Transplantation.
Started in 2000; 25 participants so far; recruitment continues
Epidemiology Research Institute. A Case-Control Study of Serious Post Transplant Lymphoproliferative Disorders in Renal Transplant Recipients.
3/7/00-2/28/02. Site Principal Investigator: Scandling, JD.
Wyeth-Ayerst Pharmaceuticals, Protocol #0468E1-100154. A Comparative, Open-Label Study to Evaluate Graft Function in De Novo Renal Allograft Recipients Treated with Either a “Reduced Dose” or a “Standard Dose” of Cyclosporine Oral Solution (Modified) or Cyclosporine Capsules (Modified) in Combination with Rapamune (Sirolimus) + Corticosteroids.
10/29/00-6/30/02. Site Principal Investigator: Scandling, JD.
Rapamune Outcomes Assessment Registry (ROAR).
8/1/01-12/31/04. Site Principal Investigator: Scandling, JD.
Novartis Pharmaceutical, Protocol CRAD001A2307. A 1-Year Multicenter, Randomized, Open-label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/day) of Certican™ (RAD001) with Simulect®, Corticosteroids and Optimized Administration of Neoral® in De Novo Renal Transplant Recipients.
9/15/01-12/30/03. Site Principal Investigator: Scandling, JD.
Novartis Pharmaceutical Extension E1 to Protocol No. CRAD001A2307, “An extension to a 1 year multicenter, randomized, open label, parallel group study of the safety, tolerability and efficacy of two doses (1.5 and 3 mg/day) of Certican™ (RAD001) with Simulect®, corticosteroids and optimized administration of Neoral® in de novo renal transplant recipients”.
Site Principal Investigator: Scandling, JD.
Award Period: 9/15/01 through April 30, 2006
Isotechnika Inc., Protocol #ISA00-16. A Phase 2, Randomized, Multicenter, Open-label Safety
Study of ISATX247 and Cyclosporine (Neoral ) in Post-Renal Transplant Patients.
10/26/01-4/25/03. Site Principal Investigator: Scandling, JD.
Roche Pharmaceuticals. Steroid-free Immunosuppression in Adult Recipients of a First Renal Allograft.
7/19/01-6/30/03. Principal Investigator: Scandling, JD.
Fujisawa Canada, Inc., Protocol # FKC-008. The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplantations Receiving Tacrolimus and Mycophenolate Mofetil
Site Principal Investigator: Busque, S.
Fujisawa Healthcare, Inc., Protocol #02-0-152 Protocol Title: A Phase II, Open-Label, Multi-Center Study to Assess the Pharmacokinetics, Long-Term Safety and Tolerability of Tacrolimus in Stable Liver Transplant Patients Converted from a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen Site Principal Investigator: Busque, S. Award Period: 12/11/02 – 11/30/07
21) Roche Pharmaceuticals Protocol Number:ML17140
Protocol Title: An open label randomized, multicenter study to evaluate the efficacy and safety of early calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on mycophenolate mofetil;MMF (CellCept®) and sirolimus (Rapamune®) Principal Investigator: Scandling, JD. Award Period: 10/1/03 – 9/30/06.
Fujisawa Healthcare, Inc., Protocol # 02-0-158 Protocol Title: A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (tacrolimus)/MMF, Modified Release (MR) Tacrolimus /MMF and Neoral®(cyclosporine)/MMF in de novo Kidney Transplant Recipients Site Principal Investigator: Busque, S. Award Period: 1/1/2004 – 12/31/2006.
Novartis Pharmaceutical, Protocol # CFTY720 0125 Protocol Title: A one-year, multicenter, partially blinded, randomized study to evaluate the efficacy and safety of FTY720 combined with reduced-dose or full-dose Neoral® and
corticosteroids versus mycophenolate mofetil (MMF, CellCept®) combined with full-dose Neoral® and corticosteroids, in de novo adult renal transplant recipients Principal Investigator: Scandling, JD
Novartis Pharmaceuticals, Protocol # Extension 1 to Protocol CFTY720 0125 Protocol Title: A two-year extension to a one-year, multicenter, partially blinded, double-dummy, randomized study to evaluate the efficacy and safety of FTY720 combined with reduced-dose or full-dose Neoral® and corticosteroids versus mycophenolate mofetil (MMF, CellCept®) combined with full-dose Neoral® and corticosteroids, in de novo adult renal transplant recipients Principal Investigator: Scandling, JD
Pfizer Inc., Protocol #A3921009 Protocol Title: A 6-month, Phase 2, multicenter, randomized, open-label, comparative study of 2 dose levels of CP-690,550 administered concomitantly with IL-2 receptor antagonist induction therapy, mycophenolate mofetil and corticosteroids versus a tacrolimus-based immunosuppressive regimen for the prevention of allograft rejection in de novo renal allograft recipients Site Principal Investigator: Busque, S. Award Period: Pending
Protocol Title: Drug Therapy and Education in the Management of Post Transplant Diabetes
Site Principal Investigator: Busque, S. IRB approval date: 12/2000
Investigator Initiated Clinical Research Experience
1. Protocol Title: Total Lymphoid Irradiation, Anti- Thymocyte Globulin and Donor Hematopoietic
Progenitor Cell Transfusion in HLA Mismatched Living Donor Kidney Transplantation NIH funding
2. Protocol Title: Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+
and T-Cell Transfusion in HLA Matched Living Donor Kidney Transplantation Site Principal Investigator: Millan, M NIH funding
Protocol Title: Randomized open lablel study comparing the metabolic control of First Kidney Transplant recipients with Pre-Existing Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a Thymoglobulin induction, prednisone free and blood monitored Cellcept immunosuppressive drug regimen Site Principal Investigator: Busque, S. IRB Approved -
Part XIV · Ginseng Establishment Insuring Agreement A. General “shade structures” means the posts and shade material used to control garden temperature and light intensity in This Part applies to ginseng seedlings, as defined in this “shade material” means either wooden lath or Except where otherwise provided, the insurance polypropylene cloth used to shade ginseng gardens.
Thomas Jefferson Health District 2009 H1N1 Influenza Update – 10/23/09 Influenza activity continues to increase throughout the state and in all age groups. • This week in Virginia surveil ance of patients seeking emergency department and urgent care treatment for suspected influenza reached 14.2%, surpassing the peak of the last two • In the U.S., hospitalization rates for la