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NCT01935128 · ClinicalTrials.gov registry record · Phase 4

Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Everolimus/Reduced Tacrolimus in Renal Transplant Recipients Following Campath® Induction

A Phase 4 study, sponsored by University of Toledo Health Science Campus.

Completed
Registry status
Phase 4
Development phase
55
Enrollment target

NCT01935128: Completed Phase 4 study, sponsored by University of Toledo Health Science Campus.

NCT01935128 is a Phase 4 study that has completed, run by University of Toledo Health Science Campus. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01935128, a Phase 4 study, has completed, sponsored by University of Toledo Health Science Campus.

COMPLETED
Registry status
Phase 4
Development phase
55 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate whether conversion to everolimus (Zortress®), allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity (measured by increased creatinine clearance) and lengthen overall graft (kidney transplant) survival (measured by 2-3 year graft survival).

Primary Outcome

Renal function in patients will be assessed using glomerular filtration rate (GFR) as measured by the Modified Diet Renal Disease (MDRD) estimation. Glomerular filtration is the process by which the kidneys filter the blood, removing excess wastes and fluids. Glomerular filtration rate (GFR) is a calculation that determines how well the blood is filtered by the kidneys, which is one way to measure remaining kidney function. GFR is also used to find the stage of chronic kidney disease. Glomerula

Interventions

  • DRUG Arm 1 Everolimus/Reduced dose tacrolimus

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2013-07-03
Est. Completion 2020-07
Phase Phase 4

What the finished NCT01935128 record still lists

NCT01935128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 1 intervention - of which Arm 1 Everolimus/Reduced dose tacrolimus is the first listed.

NCT01935128 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01935128 about?

NCT01935128 is a clinical study titled "Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Everolimus/Reduced Tacrolimus in Renal Transplant Recipients Following Campath® Induction". The purpose of this study is to evaluate whether conversion to everolimus (Zortress®), allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity (measured by increased creatinine clearance) and lengthen overall graft (kidney transplant) survival (measured by 2-3 yea...

What is the current status of trial NCT01935128?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2013-07-03. Estimated completion is 2020-07.

What interventions are being tested in trial NCT01935128?

The interventions under investigation include: Arm 1 Everolimus/Reduced dose tacrolimus (DRUG).

Who is sponsoring clinical trial NCT01935128?

This trial is sponsored by University of Toledo Health Science Campus, which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01935128's enrollment target sits among peer trials

55 1218th of 2000 higher than 778 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01935128, the US trial registry maintained by the National Library of Medicine. NCT01935128 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.