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 -
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November 2012 Promoting and sharing of development experience and debate on Sustainability of NDA funded projects BACKGROUND INTRODUCTION The National Development Agency provides grant funding to projects/programmes coupled with capacity building in order to ensure sustain-ability of these projects and programmes at the function even if donor funding were not to end of the