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

Sponsor

AlloCure Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01602328

Collaborator

(none)

156

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Biological: AC607 Biological: Vehicle Only	Phase 2

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AC607 Treatment with AC607	Biological: AC607 AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight Other Names: allogeneic bone marrow-derived human mesenchymal stem cells
Placebo Comparator: Placebo Treatment with Placebo	Biological: Vehicle Only The dose will be calculated and recorded in the same way as for AC607.

Arm

Intervention/Treatment

Active Comparator: AC607

Treatment with AC607

Biological: AC607

AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight

Other Names:

allogeneic bone marrow-derived human mesenchymal

stem cells

Placebo Comparator: Placebo

Treatment with Placebo

Biological: Vehicle Only

The dose will be calculated and recorded in the same way as for AC607.

Outcome Measures

Primary Outcome Measures

Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values. [Within 30 days of dosing.]
The first occurrence of a post-dosing serum creatinine level that is equal to or less than the subject's pre-operative baseline level.

Secondary Outcome Measures

All-Cause Mortality or Dialysis (composite endpoint). [Subjects who died or received dialysis within 30 and 90 days after dosing.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California, San Diego	San Diego	California	United States	92103
3	Stanford Hospital and Clinics	Stanford	California	United States	94305-2299
4	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
5	Northwestern University	Chicago	Illinois	United States	60611
6	Maine Medical Center	Portland	Maine	United States	04102
7	Johns Hopkins University	Baltimore	Maryland	United States	21287
8	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
9	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
10	Henry Ford Hospital	Detroit	Michigan	United States	48202
11	Mayo Clinic	Rochester	Minnesota	United States	55905
12	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
13	Columbia University Medical Center	New York	New York	United States	10032
14	Duke University Medical Center	Durham	North Carolina	United States	27710
15	Ohio State University	Columbus	Ohio	United States	43210
16	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
17	UTHealth, The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
18	Fletcher Allen Health Care - Renal Services	Burlington	Vermont	United States	05401
19	University of Virginia Health System	Charlottesville	Virginia	United States	22908
20	University of Washington Medical Center	Seattle	Washington	United States	98195
21	CAMC Clinical Trials Center	Charleston	West Virginia	United States	25304
22	Foothills Medical Centre	Calgary	Alberta	Canada	T2N 2T9
23	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2B7
24	University of Manitoba - St. Boniface Hospital	Winnipeg	Manitoba	Canada	R2H 2A6
25	CDHA Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 3A7
26	McMaster - Hamilton General Hospital / TAARI	Hamilton	Ontario	Canada	L8L 2X2
27	London Health Sciences Centre, University Hospital	London	Ontario	Canada	N6J 1S1
28	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
29	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
30	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
31	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Quebec		Canada	G1V 4G5