| No | Title | IRB # | Role |
| 1 | A phase I trial of Multi-visceral Transplantation Under Immunosuppression with FK 506 | IRB 23 PUH940151 880229 | Co-investigator
PI – Starzl |
| 2 | A trial of Liver Transplantation Under Immunosuppression with FK 506 | IRB 50 PUH890722 | Co-investigator
PI – Starzl |
| 3 | A trial of Kidney Transplantation Under Immunosuppression with FK 506 | IRB 63 CHP | Co-investigator
PI – Shapiro |
| 4 | A Randomized Trial of Primary Cadaver and Primary Living Donor Kidney TX Under Immunosuppression with FK 506 at the U of P | IRB 74 PUH900112 | Co-investigator
PI – Starzl |
| 5 | A Non-Randomized Trial of Cadaver and Living Donor Kidney RETX and Other Patients not Qualified for a Randomized Trial Under Immunosuppression with FK 506 at U of P | IRB 75 PUH900113 | Co-investigator
PI – Starzl |
| 6 | A Randomized Trial of Primary Liver TX Under Immunosuppression with FK 506 versus CYA at the U of P | IRB 76 PUH910768 | Co-investigator
PI – Fung |
| 7 | A Non-Randomized Trial of Cadaver Liver RETx and Tx of Other Liver Recipients not Qualified for a Randomized Trial Under Immunosuppression with FK 506 | IRB 77 PUH910544 | Co-investigator
PI – Fung |
| 8 | A Non-Randomized Trial of Cadaver Transplantation Under Immunosuppression with FK 506 | IRB 142 PUH940158 | Co-investigator
PI – Fung |
| 9 | Use of Mycohenolate Mofetil RS61443 for Prograf/Cyclosporine Related Chronic Nephrotoxicity in Post Transplant Liver Recipients | IRB 187PUH940816 | Co-PI |
| 10 | Investigation of Factors Affecting the Oral Absorption of Tacrolimus | IRB 193 PUH950954. | Co-investigator
PI – Venkataramanan |
| 11 | Clinical Trial to Evaluate Pro-Trac II Elisa for Measuring Tacrolimus FK 506, Prograf in the Whole Blood of Pediatric Liver Transplant Patients | IRB 201CHP new | Co-investigator
PI – Venkataramanan |
| 12 | Prospective Randomized Trial for Tacrolimus and Steroids Versus Tacrolimus, Steroid and Mycophenolate Mofetil in Post-Liver Transplant Recipients | IRB 950724-9608. | Co-PI
PI – Fung |
| 13 | Prospective, Randomized Trial of Tacrolimus/Prednisone with Zenapax Induction versus Tacrolimus/Prednisone/Mycophenolate Mofetil in Cadaveric Kidney Recipients | IRB 204 PUH980315. | Co-investigator
PI – Shapiro |
| 14 | A Randomized, Open-Label, Two-Part Study of Tacrolimus versus Cyclosporine and Sirolimus Followed by Continued Cyclosporine or Cyclosporine Withdrawal in Recipients of Orthotopic Liver Transplants | IRB 206 PUH980828 | Co-investigator
PI – Fung
Co-PI – Sindhi |
| 15 | Pharmacokinetics Study of Oral Sirolimus for Treatment of Refractory Liver Allograft Rejection and Prophylaxis in Transplant Patients at Risk for Allograft Rejection in Whom Approved Agents and Contraindicated, not Tolerated or Ineffective | IRB 201 PUH new | Co-investigator
PI – Fung
Co-PI’s – Sindhi / Venkataramanan |
| 16 | Neoral® Treatment Protocol for Compassionate Need, in Patients Unable to Adequately Absorb Sandimmune – Donnelley Hammer | IRB 2101 PUH95CC06 | PI
Co-PI – Fung |
| 17 | A Prospective Randomized Study in High-Risk Adult Liver Transplant Recipients to Compare Therapy Using Intravenous Gancylovir to Pre-emptive Therapy Using Intravenous Gancyclovir Together with Oral Gancylovir Prophylactic Therapy | IRB 2201 PUH980770 | Co-PI
PI – Kusne |
| 18 | A Phase I Trial Single Dose Trial of Hepapoietin (HPO, Recombinant Hapatocyte Growth Factor) HPO in Patients with Chronic Liver Failure | IRB 2206 PUH981217 | Co-investigator
PI – Fung
Co-PI – Demetris |
| 19 | An Open-Label, Active-Controlled Study to Evaluate the Use of Cellcept® Mycophenolate Mofetil, MMF in Post Liver Transplant Patients in Renal Impairment who are Currently on FK 506 | NR 15715 IRB 971256 | PI
Multi-center study |
| 20 | Open Label Study of Neoral® as Primary Immunosuppession Therapy in Transplant Patients Who Are Unable to Maintain Satisfactory Immunosuppression of Prograf Tacrolimus | IRB 202 PUH971256 | PI
Multi-center study |
| 21 | A One-Year Multi-center, Randomized Placebo-Controlled, Double-Blind, Parallel Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SDZ RAD in De Novo Liver Transplant Recipients | IRB 2213 PUH new | Co-Investigator
PI – Dodson |
| 22 | Drug Metabolism in Liver Transplant Patients | IRB 2114 PUH951163931288. | Co-Investigator
PI – Burckart |
| 23 | Pharmacokinetics of Mycophenolate Mofetil in Transplant Patients | IRB 2119 PUH950803 | PI |
| 24 | Drug Excretion in Transplant Patients | IRB 2121 PUH951289941234. | Co-Investigator
PI – Venkataramanan |
| 25 | Sirolimus Rapamune®, rapamycin 0468E1-220-US: A Phase II, open-label, concentration-controlled, randomized study of conventional-dose tacrolimus plus corticosteroids compared with reduced-dose tacrolimus plus sirolimus and corticosteroids in recipients of orthotopic liver allografts Wyeth-Ayerst. | IRB 2247PUH000659 | Co-Investigator
PI – Fung |
| 26 | A randomized, open-label reference study of Gengraf® compared to Neoral® in stable organ transplant subjects. | IRB 2249PUH000558 | PI
Co-PI Fung. |
| 27 | A prospective, randomized study in high-risk adult liver transplant recipients to compare therapy using intravenous Ganciclovir to pre-emptive therapy using intravenous Ganciclovir together with oran Ganciclovir prophylactic therapy. | IRB 2201PUH980770 | Co PI
PI – Kusne |
| 28 | An open label, active-controlled study to evaluate the use of Cellcept® Mycophenolate Mofetil, MMF in post-liver transplant patients in renal impairment who are currently on Neoral® Cyclosporine A, | IRB 2249PUH000558 | PI |
| 29 | Evaluation of first 5,000 liver transplant patients from the University of Pittsburgh. Analysis, survival, retransplant, causes of death, causes of graft failure and immunosuppressive-related complications. | IRB 2253PUH000625 | PI |
| 30 | Use of Mycophenolate Mofetil for Prograf/Cyclosporine-related chronic nephrotoxicity in post-transplant liver recipients. | IRB 187PUH940816 | PI |
| 31 | A prospective, randomized trial for tacrolimus and steroids vs. tacrolimus, steroids and Mycophenolate Mofetil in post-liver transplant recipients. | IRB 192PUH9507249608 | Co-PI
PI – Fung |
| 32 | An open-label, active, controlled study to evaluate the use of Cellcept® Mycophenolate Mofetil, MMF in post-liver transplant patients in renal impairment who are currently on tacrolimus. | IRB 211PUH981052 | PI |
| 33 | A randomized, comparative trial of Prograf tacrolimus in combination with sirolimus or Mycophenolate Mofetil after liver transplantation. | IRB 218PUH010210 | Co-PI
PI Fung |
| 34 | Enhancement of liver allograft survival by singler perioperative infusions of bone marrow cells from the same donor. | IRB 137 PUH960233 | Co-Investigator
PI Fung |
| 35 | A phase I, open label, multicenter study to evaluate the pharmacokinetics and tolerability of tacrolimus and sirolimus when used in combination in stable renal transplant recipients. | IRB 214 PUH | Co-Investigator
Shapiro |
| 36 | A multicenter, open label, single arm, exploratory study to assess the safety and tolerability of reduced-dose tacrolimus with RAD in maintenance renal transplant recipients with renal insufficiency. | 217PUH000712 | Co-Investigator
PI Scantlebury |
| 37 | Exploritory Cyclosporin concentration, pre dose Co versus 2 hour post dose C2 monitoring in post liver transplant patient. | | PI |
| 38 | Multicenter trial in Entercavir v/s Adefovir Comparison of the efficacy and safety of Entecavir v/s Adefovir in subjects chronically infected with heapatitis B virus. | | PI |
| 39 | Multicenter use of Rapamycin for tacromlimus related nephrotoxicity in post liver transplant patients | | Co-Investigator |
| 40 | Estimation of concentration and its metabolites in blood and plasma from left over blood which is collected for cyclosporine or tacrolimus levels. | | PI |
| 41 | Hepatitis C viral HCV antibody titre in peripheral blood from leftover sample of blood for HCV PCR. | | PI |
| 42 | Retrospective review of existing data on 250 post liver and Kidney transplant who received IV MMF. | | PI |
| 43 | Outcome of Hepatitis C patients co-infected with Cytomegalovirus CMV infection Post Liver Transplant | | Co-investigator |
| 44 | Survival & Outcomes in Hepatitis C infected Liver Transplant recipients with Hepatocellular Carcinoma | | Co-investigator |
| 45 | Optimal use of Extended Criteria Organs in the MELD area | | Co-investigator |
| 46 | Retrospective review of Existing data on Living Liver Donors | | Co-investigator |
| 47 | Retrospective review of existing data on 37 living donor liver recipients with a history of Laennec’s Cirrhosis | | Co-investigator |
| 48 | Extended Criteria donor Livers: Creating a statewide Database | | Co-investigator |
| 49 | Retrospective review of existing data on post liver transplant receiving sirolimus | | PI |
| 50 | Retrospective review of existing data on 250 post liver and kidney transplant who received IV MMF | | PI |
|
51 | Pharmacokinetics of intravenous / oral MMF and oral
Tacrolimus in live donor and deceased donor liver transplant patients | |
PI |
| 52 | A bioequivalence
study comparing ganciclovir from the valganciclovir syrup formulation
and the commercial valganciclovir 450mg tablet (Valcyte®) at a dose of
900mg in kidney transplant recipients | |
PI |
| 53 | Retrospective
evaluation of Living Liver Donors and Recipients | |
PI |
| 54 | A phase IIB,
randomized, multicenter, open-label, concentration-controlled, safety
study of ISA247 and tacrolimus (Prograf®) in de-novo renal
transplant patients | ISA05-01
WIRB: 1073468 | PI |
| Drug Disposition in Liver Transplant Patients | NIH
12/1988 - 11/1991 ($562,486) | Co-investigator
PI - Gilbert J. Burckart |
| Clinical Trial of FK 506 in Liver and Renal Transplant Patients | Fujisawa Pharmaceuticals
10/1988 to 9/1990 ($90,000) | Co-investigator
PI – Starzl |
| Analysis of FK 506 in Transplant Patients | Fujisawa Pharmaceuticals
6/1989 – 5/1991 ($80,000) | Co-investigator
PI – Starzl |
| Interaction of FK 506 and Fluconazole | Pfizer Pharmaceuticals, 6/1992 to 5/1993
($100,000) | Co-investigator
PI – Venkataramanan |
| Disposition in Liver Transplant Patients | NIH
7/94-6/1995 ($131,560)
1995-1996 ($136,783) | Co-investigator
PI – Burckart |
| FK 506 Kinetics in Patients with Liver Disease | Fujisawa Pharmaceuticals
1994-1997 ($65,621) Supplement $10,000. | Co-investigator
PI – Venkataramanan |
| FK 506 Studies-Data Analysis | Fujisawa Pharmaceuticals, 1995 ($10,000) | Co-investigator
PI – Venkataramanan |
| FK 506 Research Studies | Fujisawa Pharmaceuticals, 1996 ($30,000) | Co-investigator
PI – Venkataramanan |
| Field Evaluation of the Abbot IMX Tacrolimus II assay: Correlation Study | Abbot Laboratories, 1996 ($20,886) | Co-investigator |
| Field Evaluation of the INCSTAR ELISA Tacrolimus Assay: Correlation Study | INCSTAR
($108,549) | Co-investigator |
| Pharmacokinetics of Mycophenolate Mofetil in Liver Transplant Patients | Roche Pharmaceuticals, 5/1997 – 12/1999
($61,398) | Co-investigator |
| Prospective randomized trial Prograf/Prednisone/MMF versus Prograf/Prednisone | Roche Pharmaceuticals 1995-97
($150,000) | Co-PI
PI – Fung |
| Prograf Kinetic Studies | Fujisawa,
1997
($10,000) | PI |
| Prograf MMF kinetic studies | Fujisawa, 1998
($10,000) | PI |
| Long-Term Results of Pediatric Liver Transplantation | Fujisawa, 1998
($10,000) | Co-PI
PI – Jorge Reyes |
| Open Label Study of Neoral as Primary Immunsuppressant Therapy in Transplant Patients Who Are Unable to Maintain Satisfactory Immunosuppression on Prograf (Tacrolimus) | Novartis Pharmaceuticals
1/1998-12/1999
($83,200) | PI |
| An Open-Label, Active-Controlled Study to Evaluate the Use of CellCept (Mycophenolate Mofetil, MMF) in Post-Liver Transplant Patients with Renal Impairment Who Are Currently on FK 506 NR15715 | Roche Pharmaceuticals, 12/1998-12/2000
($141,627) | PI |
| Predicting Outcome in Alcoholic Liver Transplant Recipient | NIH
K08AA00257/01
June 1998-May 2003
($659,791) | Consultant
PI Andrea DiMartini |
| Long-term outcome of Immunosuppression |
Fujisawa
1999: ($25,000)
2000: Unrestricted | |
| Use of sirolimus for Prograf-related nephrotoxicity | Wyeth, 2001-2002
($ 57,000) | |
| Multicenter study of sirolimus (Rapamune, Rapamycin) 0468E1-220-US: A Phase II, Open-Label, Concentration-Controlled, Randomized Study of Conventional-Dose tacrolimus plus corticosteroids compared with Reduced-Dose tacrolimus plus sirolimus and corticosteroids in recipients of orthotopic liver allografts | Wyeth-Ayerst, 2001
($ 250,000) | Co PI |
| Sirolimus for primary pancreatic transplantation | Wyeth
($ 5,000) | |
| Exploration of clyclosporine C2 monitoring in liver transplant patient | Novartis
($ 128,000). | PI |
| Multicenter trial in Entercavir v/s Adefovir Comparison of the efficacy and safety of Entecavir v/s Adefovir in subjects chronically infected with heapatitis B virus |
Bristol-Myer Squibb
($ 72,000) | PI |
| Multicenter use of Rapamycin for tacromlimus related nephrotoxicity in post liver transplant patients | Wyeth
($ 250,000) | Co-investigator |
|
Pharmacokinetics of intravenous / oral MMF and oral Tacrolimus in live
donor and deceased donor liver transplant patients |
Hoffmann-La Roche Inc. ($ 141,000) | PI |
|
A bioequivalence study comparing ganciclovir from the valganciclovir
syrup formulation and the commercial valganciclovir 450mg tablet (Valcyte®)
at a dose of 900mg in kidney transplant recipients |
Roche
($ 115,652) | PI |
| A phase IIB,
randomized, multicenter, open-label, concentration-controlled, safety
study of ISA247 and tacrolimus (Prograf®) in de-novo renal transplant
patients | Isotechnika Inc.
($ 197,613) | PI |
