A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

NCT01608412 | Unknown Phase 4 DMC

• 1 other identifier: CRAD001ABR19T
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypotheses to be tested in this study are:

• Conversion to everolimus at 3 months post-transplantation is safe and effective;
• Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;
• Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.

Conditions

Kidney Transplant Recipients

Keywords

renal transplantation; everolimus; tacrolimus; molecular evaluation

Outcome Measures

Primary Outcomes (1)

• Evaluate cumulative patient and graft survival at 12 months post conversion

  Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis

  one year

Secondary Outcomes (1)

• Evaluation of estimated glomerular filtration rate 12 months post-conversion

  one year

Study Arms (2)

Tacrolimus

ACTIVE COMPARATOR

The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy. Intervention arm: Tacrolimus

Drug: Tacrolimus

Everolimus

ACTIVE COMPARATOR

The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy. Intervention arm: Everolimus

Drug: Everolimus

Interventions

Tacrolimus DRUG

TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred

Tacrolimus

Everolimus DRUG

Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

Everolimus

Eligibility Criteria

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

You may qualify if:

• Patients undergoing their first living- or deceased-donor kidney transplant who maintain a functioning graft 3 months post-transplant;
• Older than 18 years;
• Panel-reactive antibodies lower than 20%;
• Baseline immunosuppression with tacrolimus, mycophenolate sodium (MPS) and prednisone at randomization at 3 months.

You may not qualify if:

• eGFR \< 35 mL/min at randomization;
• Urine protein-to-creatinine ratio \> 0.8 at randomization;
• Episode of acute rejection with Banff histological classification \> 1A in the first 3 months post-transplant;
• Cholesterol \> 350 mg/dL or triglycerides \> 400 mg/dL with therapy at randomization;
• Active infection at randomization;
• Chronic liver disease;
• Refusal to participate in the study;
• Contraindications to kidney biopsy;
• Biopsy findings at 3 months post-transplant including borderline rejection, cellular rejection or antibody-mediated rejection.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Interventions

Tacrolimus; Everolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Sirolimus

Study Officials

• Luiz Felipe S. Gonçalves, MD

  HCPA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz Felipe S. Gonçalves, MD

CONTACT

lfgoncalves@hcpa.ufrgs.br

Nisséia Jahn, RN

CONTACT

nisseia@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 31, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 31, 2012

Record last verified: 2011-08

Locations

BR (1)