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NCT03841097 · ClinicalTrials.gov registry record · Phase 4
Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants
A Phase 4 study of Kidney Transplant; Complications, sponsored by Roy D. Bloom, MD.
- Active
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03841097 is a Phase 4 study of Kidney Transplant; Complications that is active but no longer recruiting, run by Roy D. Bloom, MD. The registered enrollment target is 60 participants, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03841097, a Phase 4 study of Kidney Transplant; Complications, is active but no longer recruiting, sponsored by Roy D. Bloom, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- DRUG Extended Release Tacrolimus Tablets
- DRUG Immediate Release Tacrolimus Capsule
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-11-11 |
| Est. Completion | 2026-05 |
| Phase | Phase 4 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower). The listed sponsor is Roy D. Bloom, MD, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT03841097 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
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.
What interventions are being tested in trial NCT03841097?
The interventions under investigation include: Extended Release Tacrolimus Tablets (DRUG), Immediate Release Tacrolimus Capsule (DRUG).
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.
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.
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Related
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