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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: Active Phase 4 study of Kidney Transplant; Complications, sponsored by Roy D. Bloom, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the change in PWV measurements (m/sec) from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
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 |
What the registry record for NCT03841097 still lists
NCT03841097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Kidney Transplant; Complications
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03841097's enrollment target sits among peer trials
60 13th of 19 higher than 5 of 19 other Kidney Transplant; Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant; Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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