NCT01976390

Brief Summary

This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 30, 2021

Completed
Last Updated

October 21, 2022

Status Verified

November 1, 2021

Enrollment Period

4.8 years

First QC Date

October 20, 2013

Results QC Date

September 30, 2021

Last Update Submit

October 19, 2022

Conditions

Renal Failure

Keywords

KidneyKidney transplantRenal failureEnd Stage Renal Diseasekidney transplant recipient

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year

    The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.

    1 Year

Study Arms (2)

Zortress (Everolimus)

ACTIVE COMPARATOR

Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.

Drug: Everolimus

Rapamune (Sirolimus)

ACTIVE COMPARATOR

Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.

Drug: Sirolimus

Interventions

EverolimusDRUG

0.75mg twice a day, Orally, starting on day of transplant

Also known as: Zortress
Zortress (Everolimus)
SirolimusDRUG

5mg, Orally, starting on day of transplant; decreasing to 3mg

Also known as: Rapamune
Rapamune (Sirolimus)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must give written informed consent before any assessment is performed.
  • Primary renal transplant recipients between ages 18 and 75 years of age.
  • Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation and practice an effective form of birth control for the duration of the study and 12 weeks after discontinuation of the study drug if applicable.

You may not qualify if:

  • Total cholesterol \> 300 mg/dl or triglycerides \> 400 mg/dl despite lipid lowering therapy
  • Pre-existing bone marrow suppression (White Blood Cell count of \< 3000, platelets \< 100,000)
  • Active infection (Hepatitis B Virus, HIV)
  • Malignancy (except for adequately treated squamous or basal cell skin carcinoma) unless patient has written clearance from an Oncologist or if patient has had no malignancy for at least 2 years prior to the transplant
  • Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte globulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Renal InsufficiencyKidney Failure, Chronic

Interventions

EverolimusSirolimus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Director of Research Operations
Organization
Division of Transplant Surgery OSUMC
brenda.cuson@osumc.edu
614-293-8021

Study Officials

  • Amer Rajab, MD

    OSU Wexner Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2013

First Posted

November 5, 2013

Study Start

October 1, 2013

Primary Completion

July 11, 2018

Study Completion

August 31, 2019

Last Updated

October 21, 2022

Results First Posted

November 30, 2021

Record last verified: 2021-11

Locations

US(1)