UnknownPhase 2

Study on Delayed Graft Function Using Paired Kidneys

Netherlands, Spain, United Kingdom12 participantsStarted 2011-08

Plain-language summary

The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from cardiac death donors who are risk for developing delayed graft function.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Subjects must sign the informed consent document prior to performance of any study related procedure including the Screening procedure.
✓. Males and females ≥ 18 years of age.
✓. Had renal transplantation due to end stage disease requiring chronic dialysis.
✓. Study drug can be administered within 6 to 36 hours after transplantation.
✓. Received kidney from donor after cardiac death.
✓. DCD kidney fulfills the clinical site's criteria for transplantation.
✓. Creatinine clearance from the transplanted kidney over a 2-hour collection period is \<10 mL/min, OR no urine output OR average urine output of \< 50 cc/H over 8 or more consecutive hours,, OR normal urine output following transplantation that diminished to average of \< 50 cc/H over 8 or more consecutive hours, OR Creatinine reduction ratio 24 hours after transplantation to pre-transplantation is \< 30%.
✓. Dry weight ≤ 100 kg.

Exclusion criteria

✕. Mean arterial pressure \<40 mmHg or cardiac index \<1.8 L/min/m2.
✕. Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
✕. Recipient of kidney from a pediatric donor age 10 years or less.
✕. Recipient age \> 75 years.
✕. Patients with ASA 4 or 5
✕. Patients with chronic obstructive pulmonary disease (COPD) GOLD IV
✕. Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy.
✕. 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 enrolment into this study.

What they're measuring

creatinine clearance

Timeframe: 7 days

Trial details

NCT IDNCT01561599

SponsorAngion Biomedica Corp

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02

View on ClinicalTrials.gov More Delayed Graft Function trials