Study on Delayed Graft Function Using Paired Kidneys
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- creatinine clearance [ Time Frame: 7 days ] [ Designated as safety issue: No ]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.
- Urine production [ Time Frame: 28 days ] [ Designated as safety issue: No ]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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]Calculated creatinine clearance at days 14 and 28
- Incidence of delayed graft function [ Time Frame: 7 days ] [ Designated as safety issue: No ]Incidence of delayed graft function (required dialysis due to inadequate renal function during the first 7 days after transplantation).
- Number of dialysis sessions [ Time Frame: 28 days ] [ Designated as safety issue: No ]Number of dialysis sessions through day 7, 14, and 28
- Mean total daily urine output [ Time Frame: 14 days ] [ Designated as safety issue: No ]Mean total daily urine output through day 14
- Daily serum creatinine [ Time Frame: 14 days ] [ Designated as safety issue: No ]Daily serum creatinine at days 1 to 7 and at days 1 to 14
- Mean serum creatinine [ Time Frame: 28 days ] [ Designated as safety issue: No ]Mean serum creatinine at days 4, 7, 10, 14, and 28
- Length of hospitalization following transplantation [ Time Frame: 28 days ] [ Designated as safety issue: No ]Length of hospitalization following transplantation
- Follow-up on graft survival and function [ Time Frame: 12 months ] [ Designated as safety issue: No ]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
- adverse and serious adverse events, and acute rejection [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]number of adverse and serious adverse events, and number of acute rejection periods
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Normal saline
Drug: Normal Saline
Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
Active Comparator: BB3
Small molecule mimetic of hepatocyte growth factor/scatter factor
Daily intravenous administration of 2mg/kg for 4 days
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.
|Maastricht University Medical Centre||Recruiting|
|Maastricht, Netherlands, 6202 AZ|
|Contact: Pieter E Hoogland, M.D. +31 43 3875938 email@example.com|
|Contact: Tim C van Smaalen +31 43 3875938 firstname.lastname@example.org|
|Principal Investigator: L. W. Ernest van Heurn, M.D., Ph.D.|
|Sub-Investigator: M.H.L. Christiaans, M.D.|
|Principal Investigator:||L. W. Ernest van Heurn, M.D.||Maastricht University Medical Centre|