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COMPLETED Phase 4

Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients

NCT01336296 · View on ClinicalTrials.gov ↗

Study Summary

This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.

Interventions

  • DRUG mycophenolic acid

Study Locations (1)

Ohio

  • University of Cincinnati Medical Center — Cincinnati

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2010-09
Est. Completion 2014-04
Phase Phase 4

Sponsor

University of Cincinnati

179 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01336296

The ClinicalTrials.gov registry entry for NCT01336296 describes a study currently listed as completed. It is categorized as Phase 4, 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 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 179 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 Kidney Transplant Recipients appearing as the primary indexed condition, and to 1 intervention — of which mycophenolic acid 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: NCT01336296 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. 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 NCT01336296 about?

NCT01336296 is a clinical study titled "Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients". This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will b...

What is the current status of trial NCT01336296?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2010-09. Estimated completion is 2014-04.

What conditions does trial NCT01336296 study?

This clinical trial studies the following conditions: Kidney Transplant Recipients. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01336296?

The interventions under investigation include: mycophenolic acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01336296?

This trial is sponsored by University of Cincinnati, which has 179 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01336296 being conducted?

This trial has 1 study location across Ohio. 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