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Active Studies (Open to Enrollment)

Thymoglobulin Induction Therapy with Minimal Immunosuppression and Evaluation of Allograft Status by Biopsy and mRNA Profiles (TIMELY Study)
Principal Investigator: Sandip Kapur, MD

This is a single center, investigator-initiated clinical trial of immunosuppression minimization. Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney transplant. It is considered to be one of the most important medications that prevent rejection of the transplant kidney by suppressing the immune system. Although tacrolimus is good at preventing rejection, it does have some unwanted side effects. These side effects include high blood pressure, increase in blood sugar, headache, and tremor. In addition, tacrolimus causes some damage to the transplant kidney over time, by causing healthy tissue to turn into scar tissue that does not function as well as healthy tissue. Therefore, kidney function may be reduced over time. In the first three months after kidney transplant, Prograf levels are generally kept between 8 to 10 ng/mL. This study will compare two groups of patients that will both have their tacrolimus dose reduced slowly over three months to prevent rejection while decreasing the risk of causing toxic effects to the kidney. One group will have their Prograf levels kept between 6 and 8 ng/mL, while the second group will have their levels kept between 3 and 5 ng/mL. We will then compare the two groups to see if there are any differences in their kidney function over time. Patients will be followed using protocol biopsies of their transplant kidney, and urine and blood samples will also be collected to gather more information on the possibility of monitoring these patients through non-invasive means.

For more information about this research study, please click here to visit the www.clinicaltrials.gov web site.

Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
Principal Investigator: Sandip Kapur, MD

In the field of kidney transplantation, many transplants are performed using kidneys from someone that died and donated their organs (called deceased donor transplantation). During the period of time after the kidney has been removed from the donor but before it is transplanted into the recipient receiving the kidney, there is a decrease in the flow of oxygen-rich blood to it. This decrease of blood flow occurs during the collection and storage of the kidney. This deceased blood flow causes injury to cells which can lead to delayed graft function (also called DGF), a condition where the kidney takes a while to "wake up" and causes the recipient to continue to require dialysis while the kidney is recovering. I5NP is a drug that is designed to temporarily stop the body from making p53, a protein that the body makes in response to the decreased blood flow to the kidney, and which causes injured kidney cells to die. I5NP may prevent injury to the kidney that can lead to DGF. The purpose of this study is to see if an experimental drug, I5NP, is safe and could be used to prevent delayed graft function. An experimental drug is one that has not been approved for marketing by the U.S. Food and Drug Administration (FDA). It can only be used for testing in clinical studies. This experimental drug has been tested in animals, and as of Spring 2010, I5NP has been given to approximately 45 people in three clinical studies. In 2009, 32 people undergoing kidney transplant surgery received I5NP. A group of independent doctors and other professionals have reviewed the safety data for all 32 kidney transplant recipients and have agreed that further studies can be conducted with this experimental drug. This research is being done because there are currently no effective therapies for the prevention of delayed graft function.

For more information about this research study, please click here to visit www.clinicaltrials.gov website.

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately after Arteriovenous Graft Creation in Patients with Chronic Kidney Disease
Principal Investigator: David Leeser, MD

This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients who have kidney disease and who are undergoing surgery to create a new graft for hemodialysis access. PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel (arteries and veins). The purpose of this study is to determine if PRT-201 when applied to a limited segment of a blood vessel immediately after surgery is safe and dilates the blood vessels. This research is being done because currently there is no effective treatment for helping blood vessels to dilate after dialysis access creation. For more information about this research study, please click here to visit www.clinicaltrials.gov website.

Recent Studies (Closed to Enrollment)

A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de novo Kidney Transplant Recipients
Principal Investigator: Sandip Kapur, MD

This is a multi-center study that will assess the safety and efficacy of Alefacept in de novo kidney transplant patients. Alefacept may enable the use of lower doses of other immunosuppressive agents, such as tacrolimus or mycophenolate mofetil, thus improving the adverse effect profile of the immunosuppression regimen.

A Phase 2, Two-Part Study of the Safety and Tolerability of Diannexin in Kidney Transplant Recipients
Principal Investigator: Sandip Kapur, MD

Kidney transplantation allows for survival and improved quality of life for patients on dialysis. Despite advances in surgical technique, patient management, and more potent anti-rejection medications, ischemia-reperfusion injury (tissue damage that occurs when the blood supply to an organ, or part of an organ, is cut off and then restored during the surgical procedure) remains an important clinical problem. The need to develop a medication that prevents or minimizes ischemia-reperfusion injury is generally recognized, however no such agents are currently available for use in transplantation. Due to organ shortages it would be advantageous if organs from non-ideal, extended-criteria donors (ECD) (older donors and donors who had high blood pressure, died from a stroke, and/or had some decrease in kidney function prior to death) could be protected from ischemia-reperfusion injury and thus be used successfully for transplantation.

Diannexin has the ability to affect blood clotting and reduce inflammation, and is in development as a therapeutic agent to prevent or minimize ischemia-reperfusion injury. Kidney transplant recipients who receive organs from deceased donors are eligible to participate. The study will take place in two parts. In the first part, increasing doses of Diannexin will be given to see which doses are best tolerated. In the second part, the doses of diannexin identified in part 1 will be studied, along with a comparison group receiving placebo (which has no active ingredients). Participants will come in for study visits for the first month after transplant, and information about how they and their transplant kidney are doing will be collected for the first transplant year.

Special Access for the Use of Voclosporin for Kidney Transplantation
Principal Investigator: Sandip Kapur, MD

This is an investigator-initiated compassionate release protocol for patients in previous Phase 2 study of ISA247 (voclosporin) for prevention of acute rejection.

Mycophenolic Acid Observational Renal Transplant Program (A Phase IV, Non-Interventional, Multi-Center, Open-Label, Prospective, Observational Study of the Safety, Effectiveness, and Tolerability of Immunosuppressive Regimens using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice
Principal Investigator: Sandip Kapur, MD

This is a multi-center registry of patients receiving mycophenolate mofetil (CellCept) vs. mycophenolic acid (myfortic) for the prevention of acute rejection after kidney transplant. It is an observational study that will follow patients after transplant and gather data regarding the efficacy and adverse effect profile of the two agents.

A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately after Arteriovenous Fistula Creation in Patients with Chronic Kidney Disease
Principal Investigator: David Leeser, MD

This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients who have kidney disease and who are undergoing surgery to create a new fistula for hemodialysis access. PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel (arteries and veins). The purpose of this study is to determine if PRT-201 when applied to a limited segment of a blood vessel immediately after surgery is safe and dilates the blood vessels. This research is being done because currently there is no effective treatment for helping blood vessels to dilate after dialysis access creation.

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