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COMPLETED Phase 1

Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure

NCT00004496 · View on ClinicalTrials.gov ↗

Study Summary

OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte stimulating hormone (alpha-MSH) in patients with acute renal failure. II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute renal failure after renal transplantation. III. Determine the safety and pharmacokinetics of alpha-MSH in patients with established ischemic acute renal failure. IV. Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics.

Conditions Studied

Interventions

  • DRUG alpha-melanocyte stimulating hormone

Study Locations (2)

Texas

  • University of Texas Southwestern Medical Center at Dallas — Dallas
  • Baylor University Medical Center — Dallas

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 1999-02
Est. Completion 2003-09
Phase Phase 1

Sponsor

University of Texas

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00004496

The ClinicalTrials.gov registry entry for NCT00004496 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Renal Failure appearing as the primary indexed condition, and to 1 intervention — of which alpha-melanocyte stimulating hormone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00004496 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00004496 about?

NCT00004496 is a clinical study titled "Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure". OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte stimulating hormone (alpha-MSH) in patients with acute renal failure. II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute renal failure after renal transplantation. III. Dete...

What is the current status of trial NCT00004496?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 1999-02. Estimated completion is 2003-09.

What conditions does trial NCT00004496 study?

This clinical trial studies the following conditions: Acute Renal Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00004496?

The interventions under investigation include: alpha-melanocyte stimulating hormone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00004496?

This trial is sponsored by University of Texas, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00004496 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial