Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors

NCT01653041 | Completed Phase 4

• 1 other identifier: CRAD001ABR26T
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Recipients from living donors kidneys HLA-identical were lower risk for acute rejection, graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen for this population. Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated with chronic use of these agents. Moreover, the use of EVR is associated with increased incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing that proteinuria may be the first indication of recurrence of the underlying renal disease, detailed information about the patient's medical history and histological analysis of the graft may contribute with additional knowledge in this area. The aim of this prospective, open, single arm study that will be performed only in the Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive regimen. This will include 100 recipients of first or second kidney transplant from a living donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a period of 12 months.

Conditions

Kidney Transplantation

Keywords

immunosuppression, identical HLA, kidney transplantation, everolimus

Outcome Measures

Primary Outcomes (1)

• Efficacy compound outcome

  Incidence of treatment failure, defined as the first occurrence of biopsy confirmed acute rejection, graft loss, death, or treatment discontinuation.

  12 months

Secondary Outcomes (1)

• acute rejection, allograft and patient survival.

  12 months

Other Outcomes (1)

• Exploratory evaluations

  12 months

Study Arms (1)

Everolimus

EXPERIMENTAL

Single arm

Drug: Everolimus

Interventions

Everolimus DRUG

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult candidates of first or repeat kidney transplant HLA identical living donors;
• Patient who signed the informed consent form to participate in this study;

You may not qualify if:

• Patients were excluded if they had been receiving immunosuppressive therapy before transplantation;
• Patients who received an investigational medication within the past 12 months;
• Patients with suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
• Patient who had had cancer (except nonmelanoma skin cancer) within the previous 2 years.
• Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives were excluded.

Sponsors & Collaborators

• Hospital do Rim e Hipertensão: lead
• Novartis: collaborator

Study Sites (1)

Hospital do Rim e Hipertensão

São Paulo, São Paulo, 04038-002, Brazil

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: April 1, 2015
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

BR (1)