NCT03088280

Brief Summary

Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

June 30, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

March 17, 2017

Last Update Submit

February 20, 2019

Conditions

Thymoglobulin Dose

Outcome Measures

Primary Outcomes (1)

  • Acute rejection

    Biopsy proven and all treated acute rejection episodes

    1 year

Secondary Outcomes (1)

  • Infection

    1 year

Study Arms (2)

3mg/kg Group

EXPERIMENTAL

Patients will received Thymoglobuline 3mg/Kg (reduced dose)

Drug: Thymoglobulin

6mg/kg Group

ACTIVE COMPARATOR

Patients will received Thymoglobuline 6mg/Kg (standard dose)

Drug: Thymoglobulin

Interventions

ThymoglobulinDRUG

reduced dose (3mg/Kg)

3mg/kg Group6mg/kg Group

Eligibility Criteria

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

You may qualify if:

  • Primary kidney transplant recipients, adults

You may not qualify if:

  • PRA \> 50%
  • DSA \> 1500 MFI
  • Retransplantation
  • Patients who are planning to receive mycophenolate instead of everolimus
  • Patients who have planning for follow-up in another center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transplant ward of the Hospital do Fortaleza

Fortaleza, Ceará, 60175-205, Brazil

Location

MeSH Terms

Interventions

thymoglobulin

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 23, 2017

Study Start

June 30, 2015

Primary Completion

January 10, 2018

Study Completion

January 1, 2020

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

patient data are confidential e will not be share with other researchers.

Locations

BR(1)