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NCT02736227 · ClinicalTrials.gov registry record · NA

Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation

A NA study, sponsored by Northwestern University.

Completed
Registry status
NA
Development phase
28
Enrollment target

NCT02736227: Completed NA study, sponsored by Northwestern University.

NCT02736227 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02736227, a NA study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
NA
Development phase
28 participants
Enrollment target

Study Summary

Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize or improve kidney function for patients with chronic kidney disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care treatment to prevent transplant liver rejection in combination with other immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a combination of two different immunosuppressants and EVL to determine if patients may have stabilized and/or improved kidney function without liver rejection. This study will look at how safe it is to slowly withdraw one anti-rejection medication while continuing to take the other medicine, and whether this can be done without liver rejection occurrence.

Primary Outcome

flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal)

Interventions

  • DRUG Tacrolimus Withdrawal and Everolimus Monotherapy

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2016-03
Est. Completion 2021-03
Phase NA
Northwestern University

1,209 total trials

What the finished NCT02736227 record still lists

NCT02736227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Tacrolimus Withdrawal and Everolimus Monotherapy is the first listed.

NCT02736227 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02736227 about?

NCT02736227 is a clinical study titled "Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation". Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize o...

What is the current status of trial NCT02736227?

This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2016-03. Estimated completion is 2021-03.

What interventions are being tested in trial NCT02736227?

The interventions under investigation include: Tacrolimus Withdrawal and Everolimus Monotherapy (DRUG).

Who is sponsoring clinical trial NCT02736227?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02736227's enrollment target sits among peer trials

28 1704th of 2000 higher than 293 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT02736227, the US trial registry maintained by the National Library of Medicine. NCT02736227 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.