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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00511407

Public ClinicalTrials.gov record NCT00511407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Although conventional hemodialysis removes waste products and corrects fluid imbalance, it does not replace critical absorptive, metabolic, endocrine, and immunologic functions performed by healthy renal tubule cells. This trial involving patients with acute renal failure evaluates the efficacy and safety of an extracorporeal renal assist device (RAD) containing human renal tubule cells connected to a conventional hemodialysis circuit. It is hypothesized that short-term (72-h) use of this cell therapeutic device will improve survival of ARF patients compared to patients receiving only conventional continuous renal replacement therapy.

Study identification

NCT ID
NCT00511407
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
RenaMed Biologics
Industry
Enrollment
58 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2004 (Type not available)
Primary completion
Aug 2007 (Actual)
Completion
Aug 2007 (Actual)
Last update posted
Dec 3, 2012

2004 – 2007

United States locations

U.S. sites
13
U.S. states
12
U.S. cities
13
Facility City State ZIP Site status
University of Alabama Birmingham Alabama 35203 —
Medical College of Georgia Augusta Georgia 30912 —
University of Chicago Chicago Illinois 60637 —
Indiana University Indianapolis Indiana 46202 —
University of Maryland Baltimore Maryland 21201 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Western New England Renal and Transplant Associates Springfield Massachusetts 01107 —
University of Michigan Ann Arbor Michigan 48109 —
Southeast Renal Associates/Presbyterian Hospital Charlotte North Carolina 28208 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Rhode Island Hospital Providence Rhode Island 02903 —
University of Texas Houston Texas 77004 —
Virginia Commonwealth University Richmond Virginia 23219 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00511407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 3, 2012 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00511407 live on ClinicalTrials.gov.

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