A Study of Experimental Medicine BB3 to Reduce the Severity of Delayed Graft Function (DGF) in Kidney Transplants

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: delayed graft function, DGF, kidney transplant, deceased donor kidney
Type: Drug study, Phase 3
Target:
30 Participants
Investigator:
Description
We invite you to take part in a research study because you are about to receive or have received a kidney transplant. Following your transplant, you may have very low to no urine output and your transplanted kidney may not work immediately. You may have a condition called delayed graft function (DGF). DGF is when the new kidney does not function properly in the first week after surgery and results in decreased urine output.

There are currently no effective therapies to prevent or treat DGF. You will receive the standard treatment for DGF if you decide not to participate in this study. The standard treatment is dialysis and kidney biopsies until the new kidney starts working well. You do not need to be in this study to receive standard care for DGF.

The purpose of this research study is to see if an investigational drug, BB3, is safe and effective for increasing the amount of urine that your new transplanted kidney will produce. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). BB3 is a growth factor-like drug, which means that it can affect cell function and growth. It is possible that BB3 can help injured organs to improve their function if it is given shortly after an injury occurs. The transplant process can injure a kidney. BB3 is given intravenously (IV) through a vein.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion Criteria:

  • All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
  • Males and females ≥ 18 years of age.
  • Oligo-anuric renal failure (< 200 mL of urine output [UO] per day) requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
  • Patient is to be the recipient of a first kidney transplant from a deceased donor.
  • Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
  • Body mass index < 35 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used.
  • Estimated donor organ cold ischemia time < 30 hours (for PMP kidneys < 40 hours).
  • Females of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year): a. Must have a negative serum pregnancy test prior to transplantation. b. Must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period OR agree to maintain total abstinence throughout the initial 30-day study period.
  • Male patients must agree to use condoms or other suitable means of pregnancy prevention such as abstinence during the initial 30-day study period.
  • Patient has poor renal function in the first 24 hours post-transplantation based on an average UO of < 50 mL/hour over any 8 consecutive hours, to maximize the likelihood that the patient requires dialysis within the first 7 days post-transplant, irrespective of pre-transplant donor and recipient risk factors.
  • Reason for low UO is not due to structural or vascular abnormalities which, when indicated should be confirmed with a renal ultrasound with Doppler study and/or vascular or urinary tract contrast studies.

Exclusion Criteria:

  • Signs and symptoms of volume depletion.
  • Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
  • Recipient of an ABO-incompatible kidney.
  • Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
  • Recipient of a kidney preserved by normothermic PMP.
  • Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
  • Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observationalinvestigation.
  • Concurrent sepsis or active bacterial infection.
  • Has an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.
  • Female who is breastfeeding.
  • History of positive human immunodeficiency virus test.
  • Requires treatment with the cytochrome P450 (CYP) 1A2 inhibitors, ciprofloxacin and/or fluvoxamine (Luvox®).
  • Unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
  • Not deemed medically appropriate for the study in the opinion of the Investigator
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $75 per visit for your
time and effort.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for about 1 year. You will be actively involved during the first 30-day study period. You will be asked to return to the transplant clinics for tests around Days 60, 90, and 180. You will be contacted by phone around Day 360.
Recruitment period
From May 3, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Macey Sockolov
Research Topic
Conditions:
  • Delayed Graft Function

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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