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Acute Renal FailurePhase 2/3NCT00286403

Vasodilators and Anti-Oxidant Therapy in Early ATN

A Phase 2/3 study testing Fenoldopam Mesylate and/or MESNA in people with Acute Renal Failure, run by Southeast Renal Research Institute at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Renal Failure
What is being tested?
Fenoldopam Mesylate and/or MESNA
How many people
0 participants
Where
2 sitesUnited States
Study dates
Aug 2008to Oct 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Post-operative patients with serum creatinine (Cr) rising 0.3 mg/dl or more than 25% above admission levels within a single 24-hour period will be considered eligible.
  • Central Venous Access: [CVP > 6 cm H2O without mechanical ventilation] [CVP > 9 cm H2O with mechanical ventilation]
  • Mean arterial pressure > 70 mm Hg receiving up to two vasopressors including:
  • Nor-epinephrine (0.01-1.5g/kg/min)
  • Phenylephrine (0.1-7.0g/kg/min
  • Vasopressin (0.1-1.5 mU/kg/min)

Who cannot join

  • Patients with APACHE scores greater than 30 (or felt by the principal investigators to be unlikely survive more than 24 hours).
  • Patients requiring 3 or more presser agents to maintain a MAP of 70 mm Hg or greater.
  • Patients on two vasopressors with a MAP < 70 mm Hg will not be considered for enrollment
  • Patient with baseline serum Cr > 3.0 mg/dl
  • Patients with known bacteremia and/or the Systemic Inflammatory Response Syndrome (SIRS)
  • Patients ATN secondary to aminoglycosides or amphotericin B or equivalent anti-fungal drug
Show all 18Show fewer
  • Patients on chronic peritoneal or hemodialysis
  • Patients receiving acute peritoneal or hemodialysis during current hospitalization
  • Patients on dopamine infusion within the previous 12 hours
  • Patients with known HIV seropositivity and past history of opportunistic infection
  • Pregnant or lactating women
  • Patients with history of uncontrolled atrial or ventricular cardiac arrhythmia
  • Patients under the influence of alcohol or other drugs
  • Patients enrolled in a previous investigational study within15 days of enrollment
  • Patients with a known hypersensitivity to fenoldopam mesylate
  • Patients with a known history of glaucoma.
  • Patients with cirrhosis of the liver and/or portal hypertension
  • Patients with toxic levels of calcineurin inhibitors (FK-506 or CsA) or acute allograft rejection

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mandeep Grewal

    Chattanooga, Tennessee, 37403

  • Chawala, M. MD

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: Combination Fenoldopam Mesylate and Intravenous MESNA (2-mercaptoethane Sulphonate)in Early Acute Kidney Injury (AKD): A Randomized, Double-Blind Placebo Controlled Clinical Trial

Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.

Read the detailed description

Primary Hypotheses:

  • Combination therapy with intravenous fenoldopam mesylate and MESNA will reduce the incidence of dialysis and all cause mortality at 21 days in patients with established acute tubular necrosis (ATN).
  • The combination of fenoldopam mesylate and Intravenous MESNA reduces the level of reactive oxygen species released following restoration of renal blood flow in patients with ischemic ATN.

Specific Aims

  1. To conduct a multicenter, double blind, trial comparing the efficacy of a 72-hour infusion of fenoldopam mesylate or combination of fenoldopam plus intravenous MESNA to reduce the incidence of dialysis or all-cause mortality at 21 days in patients with ischemic ATN.
  2. To determine the effects of fenoldopam mesylate alone or in combination with MESNA on reperfusion injury as evidenced by changes in the level of urinary 15-F2t-isoprostanes The rational is that failure of parenteral vasodilators to reduce the incidence of death or dialysis among patients with ATN may involve the extension of tubular injury through normalization of renal blood flow and subsequent reperfusion injury. Moreover, the generation of reactive oxidative species in areas of hypoxia could blunt impair regional blood flow in the kidney through inhibition of nitric oxide production.
  3. To serially measure the urinary content of ICAM-1, VCAM-1, KIM-1, P-selectin, E-selectin, MCP-1and Cyr-61 and determine the ability of specific markers to identify patients progressing to dialysis dependent ATN.

The rational is that ICAM-1 is expressed by ischemic endothelium and facilitates neutrophile migration into areas of necrotic epithelium. We will determine whether rising urinary ICAM-1 will identify patients with progressive dialysis-dependent ATN. Specific aim #3 will also examine whether a reduction in dialysis or all cause mortality by fenoldopam mesylate correlates with reduced urinary expression of ICAM-1 or other cell adhesion molecules. The serum, plasma, urine supernatant and urinary casts obtained from patients enrolled in this trial will be made available to other investigators involved in the study of early ATN.

Being tested
Fenoldopam Mesylate and/or MESNA
Keywords
Acute Tubular Necrosis, antioxidants, Fenoldopam
Medical subject headings
Acute Kidney Injury, Kidney Cortex Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fenoldopam Mesylate and/or MESNADrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Death or Dialysis at 21 days

Secondary outcomes (1)

  1. Peak serum Cr and Duration of ICU stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2006 (estimated)
  2. Study startAug 2008
  3. Primary completionOct 2008
  4. Study completionOct 2008

Why it stopped: The study was terminated due to logistics at a local hospital.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00286403
Sponsor's protocol ID
MCAT-1
Status last verified
Mar 2016
First submitted
1 Feb 2006
Last updated
28 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Tumlin JA, Finkel KW, Murray PT, Samuels J, Cotsonis G, Shaw AD. Fenoldopam mesylate in early acute tubular necrosis: a randomized, double-blind, placebo-controlled clinical trial. Am J Kidney Dis. 2005 Jul;46(1):26-34. doi: 10.1053/j.ajkd.2005.04.002.

    PubMed 15983954

  • Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

    PubMed 39607014

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fenoldopam Mesylate and/or MESNA in people with Acute Renal Failure, run by Southeast Renal Research Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Death or Dialysis at 21 days. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00286403, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.

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