BB3 in kidney transplantation Version 6.0

• Research type

  Research Study

• Full 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

• IRAS ID

  105182

• Contact name

  David Talbot

• Sponsor organisation

  Angion Biomedica Corp.

• Eudract number

  2010-019243-19

• Clinicaltrials.gov Identifier

  NCT01561599

• Research summary

  This is a pilot study designed to evaluate the safety and activity of BB3, a small-molecule hepatocyte growth factor (HGF) mimetic compared to placebo in improving renal function in the immediate post-transplant period in patients who received Donors after Cardiac Death (DCD) kidney transplantation. The study is a double-blind, placebo-controlled, paired-kidney randomised clinical trial on wait-listed dialysis patients who receive a DCD kidney transplantation and have a creatinine clearance <10 mL/min in the first 2 hours after kidney transplantation. Paired-kidney design means that the recipients of the two kidneys from the same donor are randomized to study treatment whenever possible. The active arm will receive 4 intravenous infusions of 2 mg/kg BB3 at 6-9, 24ñ3, 48ñ3 and 72ñ3 hours following kidney transplantation, and the placebo arm will receive an equal volume of normal saline at the same time points. The primary efficacy endpoint is the comparison of creatinine clearance (CrCl) as assessed by selective 24-hour urine collections from the donor kidney, starting from the first infusion of the study drug, to day 7 post-transplant. All subjects who receive the trial drug (BB3 or placebo) will be monitored for safety. Blood samples will be obtained pre-infusion and post-infusion at specified time points for pharmacokinetic (PK) and metabolite analysis. The need for dialysis will be monitored daily for 7 days after transplant and on days 10, 14 and 28. Exploratory evaluation of biomarkers for acute kidney injury will be conducted. 6 and 12 month data on graft survival and renal function will be assessed.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0223

• Date of REC Opinion

  18 Jun 2012

• REC opinion

  Further Information Favourable Opinion