Study on Delayed Graft Function Using Paired Kidneys
- Registration Number
- NCT01561599
- Lead Sponsor
- Angion Biomedica Corp
- Brief 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.
- Detailed Description
Renal transplantation is the most effective and cost-efficient form of renal replacement therapy for a burgeoning population that presents with end-stage renal disease. Although organ donation has become a national priority, the gap between the number of patients awaiting a kidney versus the number of available kidneys continues to widen exponentially. In many countries within the European Union, utilization of "donation after cardiac death" (DCD) kidneys is steadily increasing, expanding the donor pool by \> 50%. Given the high incidence of cardiac deaths in the US, aggressive pursuit of the DCD kidney pool could potentially reduce waitlist periods to months, if not days. Risk for delayed graft function (DGF) with the attendant risks for increased recipient morbidity, chronic allograft nephropathy and increased medical costs has however tempered DCD kidney utilization in this country. Development of strategies that limit normothermic reperfusion injury, promote renal repair, reduce the incidence and/or duration of DGF and improve long-term outcome can greatly enhance acceptance and recruitment of DCD kidneys. The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from DCD donors who are risk for developing DGF. This trial is unique in that it compares drug versus placebo outcome in kidney recipients from the same donor with direct evaluation of function (creatinine clearance) in the graft.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline Normal Saline Placebo BB3 BB3 Small molecule mimetic of hepatocyte growth factor/scatter factor
- Primary Outcome Measures
Name Time Method creatinine clearance 7 days The primary analysis to assess the activity of BB3 compared to placebo will be the mean difference in creatinine clearance over time using selective 24-hour urine collections from the transplanted kidney from the first infusion of study drug through day 7 post-transplant.
- Secondary Outcome Measures
Name Time Method Urine production 28 days Median time (days) until production of ≥1 litre urine over a 24-hour period, i.e. median number of days following the first infusion of study drug until the first day (08:00 - 08:00) that urine production was ≥1 litre over a 24-hour period.
Creatinine clearance 28 days Calculated creatinine clearance at days 14 and 28
Mean serum creatinine 28 days Mean serum creatinine at days 4, 7, 10, 14, and 28
Incidence of delayed graft function 7 days Incidence of delayed graft function (required dialysis due to inadequate renal function during the first 7 days after transplantation).
Number of dialysis sessions 28 days Number of dialysis sessions through day 7, 14, and 28
Mean total daily urine output 14 days Mean total daily urine output through day 14
Daily serum creatinine 7 days Daily serum creatinine at days 1 to 7
Length of hospitalization following transplantation 28 days Length of hospitalization following transplantation
Follow-up on graft survival and function 12 months Results of the 6- and 12-month follow-up on graft survival and function will be summarized as an addendum to the final clinical study report
Trial Locations
- Locations (3)
Maastricht University Medical Center
🇳🇱Minderbroedersberg, Maastricht, Netherlands
Hospital Clínico San Carlos
🇪🇸San Carlos, Madrid, Spain
The Newcastle Upon Tyne Hospital
🇬🇧Newcastle, metropolitan county of Tyne and Wear, United Kingdom