Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00280072
Other study ID # RAD-003
Secondary ID
Status Terminated
Phase Phase 2
First received January 18, 2006
Last updated November 29, 2012
Start date January 2006
Est. completion date August 2007

Study information

Verified date November 2012
Source RenaMed Biologics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

- The purpose of this study is to evaluate the safety and efficacy of the RAD to determine whether the RAD is effective in reducing mortality in patients with Acute Renal Failure due to Acute Tubule Necrosis and to evaluate the safety of the RAD

- If the RAD works normally when used for as long as 72 hours

- If the RAD will provide added benefits to normal CVVH therapy for patients with Acute Renal Failure


Description:

Acute Renal Failure (ARF)is a severe inflammatory disease state often accompanied by Multi-Organ Failure (MOF) and Systemic Inflammatory Response Syndrome (SIRS). ARF is precipitated by many factors and is most often linked to the loss of kidney tubule cell function. Patients with ARF are treated in the intensive care units of hospitals and recovery of renal function is vitally important to their survival. Current therapy for ARF involves conventional kidney support with continuous renal replacement therapies (CRRT). Despite advances in treating patients with CRRT, ARF has an extremely high mortality rate (55-70%) and requires extensive hospital stays, predominantly in the ICU. The RAD is designed to both treat ARF with MOF and/or SIRs and facilitate the natural recovery of a patient's own kidney function. The RAD is intended for use for short periods of time in conventional extracorporeal therapeutic systems that are already available in the hospital. The RAD therapy operates outside the body, and is designed to mimic the structure and function of the natural kidney. In this manner it is intended to replace the missing metabolic, endocrine, and immunologic functions of the kidney and allow time for the patient's own kidneys to resume normal functions.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- A clinical diagnosis of Acute Tubular Necrosis (ATN)

- At least one non-renal organ failure

Exclusion Criteria:

- A renal transplant at any time

- Chronic renal failure occurring due to reasons other than Acute Tubular Necrosis (ATN)

- Chronic

- Chronic immunosuppressive therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Device:
Renal Assist Device


Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States University of Maryland Baltimore Maryland
United States University of Alabama Birmingham Alabama
United States Brigham & Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Southeast Renal Associates Charlotte North Carolina
United States University of Chicago Chicago Illinois
United States Ohio State University Medical Center Columbus Ohio
United States Denver Nephrologists, PC Denver Colorado
United States University of Texas Houston Texas
United States Indiana University Indianapolis Indiana
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States WNERTA Springfield Massachusetts
United States Washington University St. Louis Missouri
United States George Washington University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
RenaMed Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate all cause mortality at Day 28
Secondary To assess the effect of RAD treatment in measures of patient's safety and clinical outcome
See also
  Status Clinical Trial Phase
Completed NCT00982527 - Fenoldopam in Pediatric Cardiac Surgery Phase 3
Completed NCT00908843 - Prevention of Contrast Induced Nephropathy (NIC) by Intravenous Versus Oral Rehydration N/A
Completed NCT00654992 - Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery Phase 2/Phase 3
Completed NCT05407272 - Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care N/A
Not yet recruiting NCT05399420 - Study of Kidney Circulating Cell-free DNA in Patients With Acute Kidney Failure
Recruiting NCT04334707 - Kidney Precision Medicine Project
Completed NCT04072432 - A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3-4 Chronic Kidney Disease Phase 1
Recruiting NCT00230412 - Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study) N/A
Completed NCT00148044 - Uremic Toxins of Patients With Acute Kidney Failure N/A
Active, not recruiting NCT04450095 - Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery Phase 2
Terminated NCT05747053 - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Completed NCT03353389 - Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang
Completed NCT03727581 - Ultrasound for Guidewire Detection
Completed NCT00912184 - Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure Phase 1/Phase 2
Recruiting NCT00522756 - Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate Therapy Phase 3
Completed NCT00484354 - Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery Phase 2
Terminated NCT00316576 - Angiotensin-Converting Enzyme Polymorphism and Acute Renal Failure (ECAREA) N/A
Completed NCT00122018 - An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery Phase 2
Unknown status NCT01359722 - N-acetylcysteine to Prevent Renal Failure N/A
Completed NCT00286273 - Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration Phase 4