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

Kidney Transplant Recipients Clinical Trial

Official title:

An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01608412
• Other study ID #: CRAD001ABR19T
• Status: Recruiting
• Phase: Phase 4
• First received: May 8, 2012
• Last updated: May 30, 2012
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Luiz Felipe S. Gonçalves, MD
• Email: lfgoncalves[@]hcpa.ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

Drug:
• Tacrolimus
TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred
• Everolimus
Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of estimated glomerular filtration rate 12 months post-conversion	- To assess the efficacy of conversion from tacrolimus to everolimus 12 months post-conversion by measuring the estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) equation	one year	No