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mTOR inhibitor

Everolimus for Kidney Failure

Phase 3

Waitlist Available

Led By Chandrashekhar Kubal, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months post-transplant

Awards & highlights

Study Summary

This trial is testing if Everolimus, with or without Mycophenolate Mofetil, is as effective as Tacrolimus plus Mycophenolate Mofetil in preventing organ rejection in liver transplant patients, without the risk of nephrotoxicity.

Eligible Conditions

Kidney Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glomerular Filtration Rate in Patients Treated With Everolimus

Glomerular Filtration Rate in Patients Treated With Tacrolimus

Number of Patients Who Experience Transplant Rejection

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107

20%

Hospitalization

20%

Immunosuppression held or modified

10%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Standard of Care

Low Intensity Tacrolimus

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study ArmExperimental Treatment1 Intervention

Everolimus as maintenance immunosuppression

Group II: Control ArmActive Control1 Intervention

Tacrolimus as maintenance immunosuppression

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

979 Previous Clinical Trials

983,012 Total Patients Enrolled

2 Trials studying Kidney Failure

14 Patients Enrolled for Kidney Failure

Chandrashekhar Kubal, MDPrincipal Investigator - Indiana University

Indiana University

1 Previous Clinical Trials

14 Total Patients Enrolled

1 Trials studying Kidney Failure

14 Patients Enrolled for Kidney Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What illnesses does Everolimus typically alleviate?

"Everolimus is not only effective for treating kidney transplant rejection, but also other conditions such as psoriasis, waldenstrom macroglobulinemia, and lung cancer."

Answered by AI

What is the mortality rate for patients taking Everolimus?

"We believe that Everolimus is safe to use (score of 3) because this drug has undergone Phase 3 clinical trials. This means that there is some evidence supporting its efficacy and multiple rounds of data confirming its safety."

Answered by AI

How many participants are included in this research?

"That is accurate, the listing on clinicaltrials.gov currently says that this study is open for recruitment. This trial was originally posted on December 19th, 2019 and edited February 4th, 2020. The aim is to enroll 104 patients from a single site."

Answered by AI

Are there any current openings for individuals in this clinical trial?

"From the information available on clinicaltrials.gov, it seems that this study is still recruiting patients. The trial was first posted on December 19th, 2019 and updated February 4th, 2020."

Answered by AI

How does the use of Everolimus compare to other drugs in clinical trials?

"As of now, 244 studies are actively researching Everolimus with 31 trials in Phase 3. Many of the clinical trials for Everolimus are located in Philadelphia, Pennsylvania, but there are 4857 total locations running clinical trials for this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function

Chandrashekhar Kubal 2019. "Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258423.