Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death.

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Subjects must sign the informed consent document prior to performance of any
study related procedure including the screening procedure.
2. Males and females * 18 years of age.
3. Had renal transplantation due to end stage disease requiring chronic dialysis.
4. Study drug can be administered within 6 to 9 hours after transplantation.
5. Received kidney from donor after cardiac death.
6. DCD kidney fulfills the clinical site*s criteria for transplantation.
7. Creatinine clearance from the transplanted kidney over a 2-hour collection period
is <10 mL/min.
8. The contralateral kidney will be transplanted at Maastricht University Medical
Center and its recipient gives consent to participate in this trial (paired-kidney
design).
9. Dry weight * 100 kg.
10. Women of child bearing potential have a negative serum pregnancy test prior to
transplantation.
11. Women of child bearing potential (including perimenopausal women who have
had a menstrual period within 1 year) must agree to use 2 forms of effective
birth control regimen (at least one-barrier method) during the 28-day study
period. Men must agree to use condoms during the study period.
12. In the opinion of the investigator, the subject is capable of understanding and
complying with the protocol.

Exclusion Criteria

1. Mean arterial pressure <40 mmHg or cardiac index <1.8 L/min/m2
2. Requires emergency dialysis for reasons other than low urine output, e.g.,
severe fluid overload, severe metabolic abnormalities
3. Recipient of multiple organ transplantation or scheduled for multiple organ
transplantation
4. Recipient of kidney from a pediatric donor age 10 years or less
5. Has measurable donor-specific antibody or positive cross-match requiring
deviation from standard immunosuppressive therapy
6. Currently participating in or has participated in an investigational drug or medical
device study within 30 days or five half-lives, whichever is longer, prior to
enrollment into this study
7. Subjects who are currently taking or within 2 weeks prior to Screening have
taken medications for Parkinson*s disease
8. Subjects who are currently taking or within 2 weeks prior to Screening have
taken medications for depression
9. Repeated demonstration of QTc interval >450 ms for males and >470 ms for
females on peri-operative and screening ECGs
10. Concurrent sepsis or active bacterial infection
11. Have an active malignancy or history of solid, metastatic or hematologic
malignancy with the exception of basal or squamous cell carcinoma of the skin
that has been removed
12. Women of child bearing potential who is breast feeding
13. History of positive HIV test
14. History of rheumatoid arthritis
15. History of proliferative retinopathy or laser surgery for retinopathy
16. Subjects who require medications metabolized by CYP1A2, or are receiving
ciprofloxacin and fluvoxamine (Luvox®)
17. Subject is unwilling or unable to comply with the protocol or to cooperate fully
with the Investigator or the site personnel
18. Subject is not deemed medically stable for the study in the opinion of the
Investigator or the subject*s primary nephrologist.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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