A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects (ACT-AKI)

AlloCure

Status and phase

Terminated

Phase 2

Conditions

Acute Kidney Injury

Treatments

Biological: AC607

Biological: Vehicle Only

Study type

Interventional

Funder types

Industry

Identifiers

NCT01602328

AC 6071103

Details and patient eligibility

About

Subjects entering the study will have undergone cardiac surgery. Those who experience kidney injury within 48 hours of their surgery will be enrolled into the study. Once enrolled, subjects will receive a single administration of AC607 or placebo. Kidney recovery will be evaluated over the subsequent 30 days and death or the need for dialysis will be evaluated within 90 days of dosing. After 90 days (evaluation period), subjects will enter a 3-year extension phase of the study to monitor safety and long-term outcomes (follow-up period).

Full description

The study will enroll post-cardiac surgery subjects (CABG and/or valve) with laboratory evidence of AKI within 48 hrs of removal from cardiopulmonary bypass. Subjects will be randomly assigned (1:1 ratio) to treatment with a single administration of AC607 or placebo (approximately 100 subjects per group).

Safety and efficacy assessments will be performed daily during the post-operative hospital stay from the day randomized into the study until discharge, at 30 days, and at 90 days after study drug administration (evaluation phase). Safety and long-term clinical outcomes will be assessed at 6, 12, 24 and 36 months (long-term follow-up phase).

Enrollment

156 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 21 years
Had cardiovascular surgery utilizing cardiopulmonary bypass
Have a pre-operative (baseline) serum creatinine value collected within 30 days of surgery (if multiple laboratory results are available within this time window, the most recent serum creatinine value prior to surgery will be used to establish the baseline)
Willing and able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up
Ability to give informed consent or have a legally acceptable representative do so for them
Have AKI defined as ≥ 0.5 mg/dL rise in serum creatinine from baseline within 48 hours of removal from cardiopulmonary bypass

Exclusion criteria

Active cancer and/or receiving active treatment for cancer, with the exception of squamous cell or basal cell carcinoma of the skin
Had surgery for thoraco-abdominal aortic aneurysm (TAAA)
Currently participating in another interventional drug or device clinical study
Prisoner or other detainee
Has a current medical condition that would preclude or compromise femoral artery catheter placement
Has an intra-aortic balloon pump (IABP) in place within 2 hours of catheter placement
Has a ventricular assist device (VAD) or extracorporeal membrane oxygenation (ECMO) in place at the time of the study catheter placement
Prior history of solid organ or bone marrow transplant
Stage 5 CKD or currently on dialysis
Are expected to receive dialysis within 24 hours of enrollment or dosing
Had a complication during surgery or post-operatively that, in the opinion of the principal investigator (PI), significantly increases the risk of complications to the subject and therefore precludes dosing the subject
Are pregnant or lactating. A woman with child-bearing potential may be tested for pregnancy at the discretion of the PI.