Study Title: 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, Part A. (IRB# 008-253)

Short Title: Quark

Study Description: Some patients, who receive a kidney transplant, are at risk of getting a condition called delayed graft function (DGF).  DGF means the new kidney does not work well during the first few weeks after transplantation. DGF happens more often when the kidney suffers reduced blood flow before the organ collection from the donor, and when the kidney is outside the body for a long time in transition from the donor to recipient.  Patients, who are diagnosed with DGF, may experience a longer hospital stay.  DGF also increases the risk of rejection of the transplanted kidney and may result in a shorter lifespan of the kidney. The purpose of this study is to see if an experimental medicine, I5NP, is safe and could be used to prevent DGF (delayed graft function). This study is randomized which means you will be assigned to receive I5NP or placebo (injection that looks like the study drug, but is inactive).  by chance, like flipping a coin. 

Some of the criteria for patients to qualify for the study include:

• Patient is at least 18 years of age.
• Patient is dialysis dependent at the time of transplant
• Patient is willing to comply with protocol

The following are some of the criteria which will exclude patients from the study:

• Patient previously received or is receiving an organ transplant other than a kidney
• Patient is planned to receive a living donor kidney

Location:
Baylor University Medical Center                  Baylor All Saints Medical Center
3500 Gaston Ave                                             1400 Eighth Avenue
Roberts Building-4th Floor                            Fort Worth, TX 76104
Dallas, TX 75246

Lead Principal Investigator: Goran Klintmalm, MD

For further information about this study, please contact: 214-820-6622 or kimberlg@baylorhealth.edu or erinf@baylorhealth.edu (Baylor All Saints Medical Center) or you can complete our online form and a research coordinator will get back to you.