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ACTIVE NOT RECRUITING Phase 4

Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants

NCT03841097 · View on ClinicalTrials.gov ↗

Study Summary

The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given once-daily each morning after transplantation or immediate release tacrolimus capsules (also known by brand name Prograf® or abbreviation IR-TAC in this study) that are administered twice-daily 12 hours apart after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of LCPT given once-daily compared to IR-TAC given twice-daily 12 hours apart after kidney transplantation.

Interventions

  • DRUG Extended Release Tacrolimus Tablets
  • DRUG Immediate Release Tacrolimus Capsule

Study Locations (1)

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2019-11-11
Est. Completion 2026-05
Phase Phase 4

Sponsor

Roy D. Bloom, MD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03841097

The ClinicalTrials.gov registry entry for NCT03841097 describes a study currently listed as active not recruiting. 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 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roy D. Bloom, MD, 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 Kidney Transplant; Complications appearing as the primary indexed condition, and to 2 interventions — of which Extended Release Tacrolimus Tablets 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: NCT03841097 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. 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 NCT03841097 about?

NCT03841097 is a clinical study titled "Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants". The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this...

What is the current status of trial NCT03841097?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2019-11-11. Estimated completion is 2026-05.

What conditions does trial NCT03841097 study?

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

What interventions are being tested in trial NCT03841097?

The interventions under investigation include: Extended Release Tacrolimus Tablets (DRUG), Immediate Release Tacrolimus Capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03841097?

This trial is sponsored by Roy D. Bloom, MD, 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 NCT03841097 being conducted?

This trial has 1 study location across Pennsylvania. 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