Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00511407
• Date of registration: 02/08/2007
• Prospective Registration: No
• Primary sponsor: RenaMed Biologics
• Public title: Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
• Scientific title: A Multi-Center, Randomized, Phase II Study To Assess Safety and Efficacy With the Renal Assist Device (RAD) In Patients With Acute Renal Failure
• Date of first enrolment: March 2004
• Target sample size: 58
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00511407
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Non-pregnant.

- Requiring continuous renal replacement therapy for treatment of acute renal failure
secondary to acute tubular necrosis in ICU setting.

- At least one non-renal organ failure or presence of sepsis.

Exclusion Criteria:

- Contraindications to systemic anticoagulation with heparin.

- Irreversible brain damage.

- Presence of any organ transplant.

- Presence of preexisting chronic renal failure prior to this episode of acute renal
failure.

- Acute renal failure 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.

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

- Chronic immunosuppression.

- Receiving Xigris therapy at time of randomization.

- Severe liver failure as documented by a Pugh Liver Failure Score.

- Do Not Resuscitate (DNR) status.

- Platelet count 35,000/mm3 within 4 hours of platelet transfusion.

- Patient not expected to survive 28-days because of an irreversible medical condition.

- Any medical condition that the investigator thinks may interfere with the study
objectives.

- Concurrent enrollment in another clinical trial that could affect the outcome of this
study protocol.

- 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 Renal Failure

Intervention(s)

Device: Renal tubule assist device

Primary Outcome(s)

Time to recovery of renal function [Time Frame: 180 d]

All-cause mortality [Time Frame: 28, 90, and 180 d]

Time to ICU and hospital discharge [Time Frame: 180 d]

Secondary ID(s)

RAD-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors