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NCT00731874 · ClinicalTrials.gov registry record · Phase 4

Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status

A Phase 4 study, sponsored by Weill Medical College of Cornell University.

Terminated
Registry status
Phase 4
Development phase
34
Enrollment target

NCT00731874 is a Phase 4 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 34 participants.

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The verdict

NCT00731874, a Phase 4 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.

TERMINATED
Registry status
Phase 4
Development phase
34 participants
Enrollment target

Study Summary

Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney transplant. It is considered to be one of the most important medications that prevent rejection of the transplant kidney by suppressing the immune system. Although tacrolimus is good at preventing rejection, it does have some unwanted side effects. These side effects include high blood pressure, increase in blood sugar, headache, and tremor. In addition, tacrolimus causes some damage to the transplant kidney over time, by causing healthy tissue to turn into scar tissue that does not function as well as healthy tissue. Therefore, kidney function may be reduced over time. In the first three months after kidney transplant, Prograf levels are kept between 8 to 10 ng/mL. This study will compare two groups of patients that will both have their tacrolimus dose reduced slowly over three months to prevent rejection while decreasing the risk of causing toxic effects to the kidney. One group will have their Prograf levels kept between 6 and 8 ng/mL, while the second group will have their levels kept between 3 and 5 ng/mL. We will then compare the two groups to see if there are any differences in their kidney function over time.

Interventions

  • DRUG Tacrolimus

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2008-08
Est. Completion 2013-07
Phase Phase 4

What the Registry Record Tells You About NCT00731874

The ClinicalTrials.gov registry entry for NCT00731874 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

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

NCT00731874 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00731874 about?

NCT00731874 is a clinical study titled "Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status". Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney transplant. It is considered to be one of the most important medications that prevent rejection of the transplant kidney by suppressing the immune system. Although tacrolimus is good at preventing rejection, ...

What is the current status of trial NCT00731874?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2008-08. Estimated completion is 2013-07.

What interventions are being tested in trial NCT00731874?

The interventions under investigation include: Tacrolimus (DRUG).

Who is sponsoring clinical trial NCT00731874?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.