Ongoing Clinical Trials

 

A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Purpose: This trial is designed to address important issues that impact recipients of liver allografts as well as clinicians, i.e. renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in Hepatitis C virus (HCV) positive patients.

ClinicalTrials.gov ID:

NCT00622869

Sponsor:

Novartis

Status:

Active, Not Recruiting

 

Planned Transition to Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients

Purpose: This study will look at the effect on long term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.

ClinicalTrials.gov ID: NCT00895583

Sponsor:

Wyeth

Status:

Active, Not Recruiting

 

Human Kidney Cell Isolation, Characterization & Expansion (ICE) Study

Purpose: The purpose of the "Human Kidney Cell ICE Study" is to determine the feasibility and efficiency of isolation and propagation of therapeutically relevant cells from normal and diseased human kidney tissue.

ClinicalTrials.gov ID: Not Applicable

Sponsor:

Tengion

Status:

Active, Enrolling

 

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

Purpose: The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

ClinicalTrials.gov ID:

NCT00114777

Sponsor:

Bristol-Myers Squibb

Status:

Active, Not Enrolling


Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (Benefit)

Purpose: The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

ClinicalTrials.gov ID:

NCT00256750

Sponsor:

Bristol-Myers Squibb

Status:

Active, Not Enrolling

 

 A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C

Purpose: This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

ClinicalTrials.gov ID:

NCT00938860

Sponsor:

Novartis Pharmaceuticals

Status:

Active, Not Enrolling

 

Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study

Purpose: To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrol) and more specifically to correlate 'Haufen' shedding with the histologically confirmed course of PVN.

ClinicalTrials.gov ID:

NCT01094691

Sponsor:

University of North Carolina, Chapel Hill and Astellas Pharma, Inc.

Status:

Recruiting

 

Feasibility of a Minimally Invasive Image Guided Surgery System for Hepatic Procedures

Purpose: To determine the accuracy of Explorer MIL System in displaying the location of a tracked radio frequency ablation (RFA) probe compared to the gold standard of intraoperative ultrasound.

ClinicalTrials.gov ID:

NCT01286428

Sponsor:

Pathfinder Therapeutics, Inc.

Status:

Recruiting

 

A Phase III, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro Tablets, Once Daily, Compared to Prograf Capsules, Twice Daily, in Combination with Mycophenolate Mofetil for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients.

Purpose: To evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once daily compared to Prograf (tacrolimus) Capsules twice daily as immunospression for the prevention of acute allograft rejection in de novo adult kidney transplant recipients treated for a 12 month study period followed by a 12 month, blinded extension treatment period.

ClinicalTrials.gov ID:

NCT01187953

Sponsor:

LifeCycle Pharma

Status:

Recruiting

 

Belatacept Conversion Trial in Renal Transplantation

Purpose: The purpose of this study is to learn if conversion to Belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied.

ClinicalTrials.gov ID: NCT00402168

Sponsor:

Bristol-Myers Squibb

Status:

Active, Not Enrolling