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RECRUITING Phase 2

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

NCT04375813 · View on ClinicalTrials.gov ↗

Study Summary

eRapa (encapsulated rapamycin) will be investigated for secondary prevention in patients with diagnosed non-muscle invasive bladder cancer (NMIBC) through a phase II double-blind randomized controlled trial of long-term (one year) prevention with eRapa versus placebo. The primary hypothesis is that eRapa decreases the risk of cancer relapse for patients with NMIBC. Secondary hypotheses are that eRapa can improve certain immune parameters and improve cognition and physical function without adversely affecting patient-reported outcomes and quality of life.

Interventions

  • DRUG Placebos
  • DRUG eRapa

Study Locations (2)

Texas

  • UT Southwestern Medical Center — Dallas
  • UT Health San Antonio — San Antonio

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2021-01-25
Est. Completion 2026-01
Phase Phase 2

Sponsor

Robert Svatek

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04375813

The ClinicalTrials.gov registry entry for NCT04375813 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Robert Svatek, 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 Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions — of which Placebos 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: NCT04375813 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 NCT04375813 about?

NCT04375813 is a clinical study titled "Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention". eRapa (encapsulated rapamycin) will be investigated for secondary prevention in patients with diagnosed non-muscle invasive bladder cancer (NMIBC) through a phase II double-blind randomized controlled trial of long-term (one year) prevention with eRapa versus placebo. The primary hypothesis is that ...

What is the current status of trial NCT04375813?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2021-01-25. Estimated completion is 2026-01.

What conditions does trial NCT04375813 study?

This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04375813?

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

Who is sponsoring clinical trial NCT04375813?

This trial is sponsored by Robert Svatek, 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 NCT04375813 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