Evaluation of Early Use of Everolimus (EVE) on Cytomegalovirus (CMV) Infection in Renal Transplant Recipients

NCT01927588 | Unknown Phase 4 DMC

• 1 other identifier: CRAD001ABR29T
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

CMV infection is common in transplant patients and can cause graft loss. CMV is a major factor in increasing morbidity, and post-transplant costs. The CMV infection is associated with many deleterious indirect effects including rejection, interstitial fibrosis and tubular atrophy, mortality. In addition to the potential for undesirable clinical outcomes associated with CMV, there is also a negative economic aspect. Patients who developed CMV events have been found to use significantly more inpatient and outpatient resources than patients without CMV disease. Universal prophylaxis is associated with high treatment cost and the potential for drug-related toxicity. It can be speculated that use of EVR may offer additional economic benefits in terms of decreased utilization associated with prevention of CMV disease, and reduce use of costly prophylaxis. Any efforts to reduce costs in renal transplants are very important and may have a great impact in total cost of a renal program. And the other hand, the clinical data suggest that EVR is associated with a decrease in CMV incidence compared to mycophenolic acid (MPA). CMV replication is dependent upon 1 ou 2 mTor pathways and in vitro studies support an association between mTor inhibitors and decreased CMV infection and disease. In cardiac transplantation, the use of EVR was associated with a lower incidence of CMV events. Some clinical trials data have also shown that use of EVR was associated with a lower incidence of CMV infection compared to MPA following renal transplantation. Brennan et al compared the incidence of CMV in three clinical trials using EVR versus MPA in De Novo renal transplants. They pooled for analysis the studies B201, B251 and A2309, all double-blind, randomized, parallel-groups that compared the incidence of freedom form and incidence of CMV between EVR groups and MPA groups. The results of this pooled analysis of over 2000 patients de novo renal transplant demonstrated that EVR was associated with a decrease in and delay in the time of onset of CMV events compared to MPA. Our hypothesis is that basiliximab in combination with low dose tacrolimus, everolimus and prednisone may result in comparable efficacy (BCAR) observed in patients receiving tacrolimus/mycophenolate/prednisone but with a better safety profile (CMV infection) and cost-effectiveness.

Conditions

Cytomegalovirus Infections

Keywords

Certican; Renal Transplant; Cytomegalovirus Infection

Outcome Measures

Primary Outcomes (1)

• Cytomegalovirus (CMV) infection investigation

  Blood samples will be collected to perform antigenemia at baseline, 1 month, 3 months 6 months and 12 months after transplant to investigate CMV infection.

  one year

Secondary Outcomes (3)

• Transplant biopsies

  One year

• C4d method

  one year

• Polyoma identification

  One year

Study Arms (2)

Everolimus+Tacrolimus+Prednisone

EXPERIMENTAL

Certican 3mg/daily for 12 months TACreduced 0,15mg/Kg/daily for 12 months Steroids 1mg/Kg/daily for 12 months

Drug: Everolimus+Tacrolimus+Prednisone

Mycophenolate+Tacrolimus+Prednisone

ACTIVE COMPARATOR

Myfortic 720mg twice daily for 12 months TACreduced full dose/Kg/daily for 12 months Steroids 1mg/Kg/daily for 12 months

Drug: Mycophenolate+Tacrolimus+Prednisone

Interventions

Everolimus+Tacrolimus+Prednisone DRUG

Certican, introduced at Day7 post transplant + TACreduced + Steroids.

Also known as: Certican, Tacrolimus, Prednisone

Everolimus+Tacrolimus+Prednisone

Mycophenolate+Tacrolimus+Prednisone DRUG

Myfortic + Tacrolimus full + Steroids, as control arm.

Also known as: Myfortic, Tacrolimus, Prednisone

Mycophenolate+Tacrolimus+Prednisone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary kidney transplants (living or deceased donors);

You may not qualify if:

• Recipients of a second transplant;
• Recipients of multiple organs transplants;
• PRA \> 50%;
• Chronic liver failure;
• Presence of uncontrolled hypercholesterolemia (≥ 250 mg/dL);
• Or hypertriglyceridemia (≥ 300 mg/dL).
• Leucocytes count \< 1500 per microliter;
• Platelets count \< 75000 per microliter;
• Proteinuria \> 800mg/day;

Sponsors & Collaborators

• Fundação Pró Rim: lead

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Everolimus; Tacrolimus; Prednisone; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Luciane M. Deboni, Msc

  Fundação Pró Rim

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciane M Deboni, Doctor, PI

CONTACT

+55 47 96094320; lmdeboni@terra.com.br

Karjan H Mazzoleni, Nurse, SC

CONTACT

+55 47 99141713; karjanhelena@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 22, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 22, 2013

Record last verified: 2013-08