Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Sponsor

Hospital Geral de Fortaleza (Other)

Overall Status

Unknown status

CT.gov ID

NCT03088280

Collaborator

(none)

200

Enrollment

Location

Arms

54.1

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thymoglobulin Dose	Drug: Thymoglobulin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Actual Study Start Date :

Jun 30, 2015

Actual Primary Completion Date :

Jan 10, 2018

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3mg/kg Group Patients will received Thymoglobuline 3mg/Kg (reduced dose)	Drug: Thymoglobulin reduced dose (3mg/Kg)
Active Comparator: 6mg/kg Group Patients will received Thymoglobuline 6mg/Kg (standard dose)	Drug: Thymoglobulin reduced dose (3mg/Kg)

Arm

Intervention/Treatment

Experimental: 3mg/kg Group

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

Drug: Thymoglobulin

reduced dose (3mg/Kg)

Active Comparator: 6mg/kg Group

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

Drug: Thymoglobulin

reduced dose (3mg/Kg)

Outcome Measures

Primary Outcome Measures

Acute rejection [1 year]
Biopsy proven and all treated acute rejection episodes

Secondary Outcome Measures

Infection [1 year]
All infections requiring hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary kidney transplant recipients, adults

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Transplant ward of the Hospital do Fortaleza	Fortaleza	Ceará	Brazil	60175-205

Sponsors and Collaborators

Hospital Geral de Fortaleza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tainá Veras de Sandes Freitas, MD PhD, Hospital Geral de Fortaleza

ClinicalTrials.gov Identifier:

NCT03088280

Other Study ID Numbers:

First Posted:

Mar 23, 2017

Last Update Posted:

Feb 22, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Thymoglobulin

Study Results

No Results Posted as of Feb 22, 2019