A phase I trial of Multi-visceral Transplantation Under Immunosuppression with FK 506

IRB 23 PUH940151 880229

Co-investigator PI – Starzl

A trial of Liver Transplantation Under Immunosuppression with FK 506

IRB 50 PUH890722

Co-investigatorPI – Starzl

A trial of Kidney Transplantation Under Immunosuppression with FK 506

IRB 63 CHP

Co-investigatorPI – Shapiro

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-investigatorPI – Starzl

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-investigatorPI – Starzl

A Randomized Trial of Primary Liver TX Under Immunosuppression with FK 506 versus CYA at the U of P

IRB 76 PUH910768

Co-investigatorPI – Fung

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-investigatorPI – Fung

A Non-Randomized Trial of Cadaver Transplantation Under Immunosuppression with FK 506

IRB 142 PUH940158

Co-investigatorPI – Fung

Use of Mycohenolate Mofetil RS61443 for Prograf/Cyclosporine Related Chronic Nephrotoxicity in Post Transplant Liver Recipients

IRB 187PUH940816

Co-PI

Investigation of Factors Affecting the Oral Absorption of Tacrolimus

IRB 193 PUH950954.

Co-investigator
PI – Venkataramanan

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

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

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

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

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

Neoral® Treatment Protocol for Compassionate Need, in Patients Unable to Adequately Absorb Sandimmune – Donnelley Hammer

IRB 2101 PUH95CC06

PI
Co-PI – Fung

A Prospective Randomized Study in High-Risk Adult Liver Transplant Recipients to Compare Therapy Using Intravenous Gancylovir to Pre-emptive Therapy Using IntravenousGancyclovir Together with Oral Gancylovir Prophylactic Therapy

IRB 2201 PUH980770

Co-PI
PI – Kusne

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

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

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

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

Drug Metabolism in Liver Transplant Patients

IRB 2114 PUH951163931288.

Co-InvestigatorPI – Burckart

Pharmacokinetics of Mycophenolate Mofetil in Transplant Patients

IRB 2119 PUH950803

PI

Drug Excretion in Transplant Patients

IRB 2121 PUH951289941234.

Co-InvestigatorPI – Venkataramanan

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

A randomized, open-label reference study of Gengraf® compared to Neoral® in stable organ transplant subjects.

IRB 2249PUH000558

PI
Co-PI Fung.

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 PIPI – Kusne

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

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

Use of Mycophenolate Mofetil for Prograf/Cyclosporine-related chronic nephrotoxicity in post-transplant liver recipients.

IRB 187PUH940816

PI

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

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

A randomized, comparative trial of Prograf tacrolimus in combination with sirolimus or Mycophenolate Mofetil after liver transplantation.

IRB 218PUH010210

Co-PI
PI Fung

Enhancement of liver allograft survival by singler perioperative infusions of bone marrow cells from the same donor.

IRB 137 PUH960233

Co-Investigator
PI Fung

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

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

Exploritory Cyclosporin concentration, pre dose Co versus 2 hour post dose C2 monitoring in post liver transplant patient.

 

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.

 

PI

Multicenter use of Rapamycin for tacromlimus related nephrotoxicity in post liver transplant patients

 

Co-Investigator

Estimation of concentration and its metabolites in blood and plasma from left over blood which is collected for cyclosporine or tacrolimus levels.

 

PI

Hepatitis C viral HCV antibody titre in peripheral blood from leftover sample of blood for HCV PCR.

 

PI

Retrospective review of existing data on 250 post liver and Kidney transplant who received IV MMF.

 

PI

Outcome of Hepatitis C patients co-infected with Cytomegalovirus CMV infection Post Liver Transplant

 

Co-investigator

Survival & Outcomes in Hepatitis C infected Liver Transplant recipients with Hepatocellular Carcinoma

 

Co-investigator

Optimal use of Extended Criteria Organs in the MELD area

 

Co-investigator

Retrospective review of Existing data on Living Liver Donors

 

Co-investigator

Retrospective review of existing data on 37 living donor liver recipients with a history of Laennec’s Cirrhosis

 

Co-investigator

Extended Criteria donor Livers: Creating a statewide Database

 

Co-investigator

Retrospective review of existing data on 250 post liver transplant who received Calgan for CMV prophylaxis

RSRB Letter of Exemption

PI

Retrospective review of 204 post LTx,HCV positive patients

RSRB Letter of Exemption

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.

RSRB 11810

PI

Retrospective evaluation of Living Liver Donors and Recipients

PI

A phase IIB, randomized, multi-center, open-label, concentration-controlled, safety study of ISA247 and tacrolimus (Prograf®) in de-novo renal transplant patients

ISA05-01 WIRB: 1073468

PI

Pharmacokinetics of intravenous / oral MMF and oral Tacrolimus in live donor and deceased donor liver transplant patients

Hoffmann-La Roche Inc. ($ 141,000) RSRB 10410

PI

A phase IIB, randomized, multi-center, open-label, concentration-controlled, safety study of ISA247 and tacrolimus (Prograf®) in de-novo renal transplant patients

Isotechnika Inc. RSRB 12809

PI

Retrospective Rernal transplant therapy outcome , Multicenter study (TTOSG-001) Fujisawa sponsered

RSRB 9834

PI

Role of rapamycin in post liver transplant (LTx) patients for calcineurin inhibitor induced nephrotoxicity/ neurotoxicity. Ashok Jain, Principal Investigator (in process of submission to RSRB)

RSRB00021411

PI

Practical algorithm to manage acute rejection in Hepatitis C Virus (HCV) positive liver transplant recipients and to study the response to anti HCV therapy

RSRB00021202

PI

Polysubstance abuse in liver transplant patients and its impact on survival outcome

RSRB00020710

PI

Immunological advantage of intravenous Mycophenolate Mofetil with tacrolimus and steroids in primary deceased donor liver transplantation and live donor liver transplantation without antibody induction

RSRB00020604

PI

Impact of trichrome stain on fibrosis score in post transplant liver biopsy in HCV positive patients Should trichrome stain be used on all post transplant liver biopsies with Hepatitis C Virus infection to estimate fibrosis score?

RSRB00020605

PI

Antigen Presenting Function of Human Liver Leukocytes – Comparison of disease to healthy liver donors

RSRB00011544

Sub-Investigator

U2205 Gene expression HCC. URCC U2205 – Gene expression profiling to predict recurrence of outside-criteria transplanted HCC: a pilot study

RSRB00012517

Sub-Investigator

SPLIT 5/8/2006 Studies of Pediatric Liver Transplantation (SPLIT)

RSRB00012208

Sub-Investigator

Belatacept- IM103008 Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial

RSRB00013728

Sub-Investigator

Entecavir Study 7/19/2007 Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

RSRB00020179

Sub-Investigator

Opticept Tsoulfas, An open label; prospective, randomized, controlled, multi-center study assessing fixed dose vs. concentration controlled CellCeptâ regimens for patients following a single organ renal transplantation in combination with full dose and reduced dose calcineurin inhibitors.

RSRB00011710

Sub-Investigator

ECD Study Bozorgzadeh, (Jain, Sub-Investigator)10/13/2005 Use of extended criteria donors in liver transplantation outcomes analysis

RSRB00012744

Sub-Investigator

A study on various kinds of infections post-liver transplantation.

20622 TUHS

Principal Investigator

Qualitative and Quantitative Changes in Urinary Drug Screen before and after liver transplant

20621 TUHS

Principal Investigator

Evaluation of Dobutamine Stress Echocardiography in Patients with Liver Failure

20619 TUHS

Principal Investigator

Reason for re-admission after liver transplant

20618 TUHS

Principal Investigator

Thrombocytopenia in End Stage Liver Disease and Improvement after Liver Transplantation

20620 TUHS

Principal Investigator

Improving Pre-transplant Survival in High MELD Score End Stage Liver Disease

20617 TUHS

Principal Investigator

Evaluation of Peginterferone and Ribavirin therapy post Liver Transplant patient

20624 TUHS

Principal Investigator

Qauntitative Assessment of the State of Immunosuppression Following Liver transplanatation

20624 TUHS

Principal Investigator

Steroid free Immunosuppression

00000909 HMC

Co-Investigator

Estimation of Renal function

00004977 HMC

Principal Investigator

Use of ERCP Stent Liver Transplantation 000003774 HMC

Principal Investigator

Testosterone deficiency with renal and liver failure patients 000003965 HMC