Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT01400893
• Date of registration: 21/07/2011
• Primary sponsor: CytoPherx, Inc
• Public title: Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
• Scientific title: A Multi-Center, Randomized, Controlled, Pivotal Study To Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) In Patients With Acute Kidney Injury (AKI)
• Date of first enrolment: August 2011
• Target sample size: 344
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01400893
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Rick Da Silva, RN

Key inclusion & exclusion criteria

Inclusion Criteria

1. A patient, or legal representative, has signed a written informed consent form.

2. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU,
CTICU, Trauma).

3. Age 18 to 80 years.

4. Females of child bearing potential who are not pregnant (confirmed by a negative
serum pregnancy test) and not lactating if recently post-partum.

5. Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not
longer than 24.

6. Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.

7. A clinical diagnosis of ATN due to hemodynamic or toxic etiologies. ATN is defined as
Acute Kidney Injury occurring in a setting of acute ischemic or nephrotoxic injury
with oliguria (average <20 mL/hr) for >6-12 hours or: an increase in serum creatinine
=2 mg/dL (=1.5 mg/dL in females) over a period of =4 days. (Note: Prerenal,
hepatorenal, vascular, interstitial, glomerular, and obstructive etiologies are
excluded on clinical or other diagnostic grounds.)

8. Presence (proven or suspected) of severe sepsis as defined in Appendix C.

9. All patients must be able to tolerate regional citrate anticoagulation.

Exclusion Criteria:

1. Irreversible brain damage based on available historical and clinical information.

2. Presence of any organ transplant at any time.

3. Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs,
ECMO.

4. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic
renal replacement therapy prior to this episode of acute kidney injury.

5. AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial
nephritis, acute or rapidly progressive glomerulonephritis, vasculitis,
hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant
hypertension, scleroderma renal crisis, atheroembolism, functional or surgical
nephrectomy, hepatorenal syndrome, cyclosporine or tacrolimus nephrotoxicity.

6. Metastatic malignancy which is actively being treated or may be treated by
chemotherapy or radiation during the subsequent three month period after study
therapy.

7. Chronic immunosuppression (e.g., HIV/AIDS, chronic glucocorticoid therapy >20 mg/day
prednisone equivalent on a chronic basis). The acute use of glucocorticoids is
permissible.

8. Severe liver failure as documented by a Child-Pugh Liver Failure Score >12 (see
Appendix F).

9. Currently in Do Not Resuscitate (DNR) status or DNR status anticipated within the
next 7 days.

10. Currently in Comfort measures Only or Comfort Measures Only status anticipated within
next 7 days.

11. Patient is moribund or chronically debilitated for whom full supportive care is not
indicated.

12. Patient not expected to survive 28 days because of an irreversible medical condition.
(This is not restrictive to AKI, and may include situations such as the presence of
irreversible brain damage, untreatable malignancy, inoperable life threatening
condition, or any condition to which therapy is regarded as futile by the PI.)

13. Any medical condition that the Investigator thinks may interfere with the study
objectives.

14. Physician refusal.

15. Patient is a prisoner.

16. Dry weight of >150 kg.

17. More than one hemodialysis treatment during this hospital admission or prior to
transfer from an outside hospital.

18. Platelet count <30,000/mm3 at time of screening.

19. Concurrent enrollment in another interventional clinical trial. Patients enrolled in
clinical trials where only measurements and/or samples are taken (NO TEST DEVICE OR
TEST DRUG USED) are allowed to participate.

20. Use of any other Investigational drug or device within the previous 30 days.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Kidney Injury

Intervention(s)

Device: SCD

Primary Outcome(s)

The Primary Clinical Efficacy endpoint in this trial is all cause mortality through 60 days post-randomization. [Time Frame: Day 60 following treatment end]

Secondary Outcome(s)

Mortality at day 28 [Time Frame: Day 28 following treatment]

Number of ventilator free days (VFD) at day 28. [Time Frame: Day 28 following treatment]

Renal Replacement Therapy dependency at day 60. [Time Frame: Day 60 following treatment end]

Time to mortality for the Severe Septic patients through day 60 [Time Frame: Day 60 following treatment]

Secondary ID(s)

SCD-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors