Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults

NCT01455649 | Unknown Phase 4

• 1 other identifier: CRAD001ABR17T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.

Conditions

Kidney Transplant; Immunosuppression

Keywords

Kidney; Transplant; Immunosuppression; Everolimus; Graft function

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Creatinine Clearance at 24 months

  The primary objective is to demonstrate the effectiveness and non-inferiority of treatment with everolimus, by assessing renal function, in comparison with the use of calcineurin inhibitor.

  baseline and two years

Secondary Outcomes (1)

• Number of Participants with Adverse Events

  baseline and two years

Study Arms (2)

Everolimus

EXPERIMENTAL

Drug: Everolimus

calcineurin inhibitor

ACTIVE COMPARATOR

Drug: calcineurin inhibitor

Interventions

Everolimus DRUG

Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).

Also known as: Certican

Everolimus

calcineurin inhibitor DRUG

Group will maintain their initial immunosuppression therapy with calcineurin inhibitor

Also known as: Tacrolimus, Cyclosporin, NeoOral, Prograf

calcineurin inhibitor

Eligibility Criteria

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

You may qualify if:

• Patients aged from 18 to 65 years old
• First transplantation recipients
• PRA \< 30%
• Living or cadaveric donor
• Stable renal function
• Patients not pregnant or breastfeeding , where pregnancy is defined as the woman status from conception to gestation conclusion, through a positive beta hCG test (\>5mUI/mL)
• Provided written informed consent form

You may not qualify if:

• Cadaveric donor with expanded criterion
• Multiple organs transplantation
• Kidney cold ischemia time \> 24 hours
• Severe rejection episode - Banf \>IIA
• Glomerular filtration rate \< 35mL/min
• Presence of hard to treat dyslipidemia - severe hypercholesterolemia (\>350mg/dL) or hypertriglyceridemia (\>500mg/dL)
• Proteinuria \> 800mg/24h
• Patients with history of malignancy of any organic system, treated or not, within 5 years, with or without evidence of local recurrence or metastases, other than localized basal cell carcinoma
• Female with childbearing potential without using a reliable contraceptive method.

Sponsors & Collaborators

• Deise de Boni Monteiro de Carvalho: lead

Study Sites (1)

Hospital federal de Bonsucesso

Rio de Janeiro, Rio de Janeiro, 21041-030, Brazil

Location

MeSH Terms

Interventions

Everolimus; Calcineurin Inhibitors; Tacrolimus; Cyclosporine

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Francisco G Miloski, MD

  Physician

  STUDY CHAIR

• Tereza Matuck, MD

  Chief of the Nephrology Department

  STUDY CHAIR

• Regina Sousa

  Head Nurse of The Nephrology Department

  STUDY CHAIR

Central Study Contacts

Deise BM Carvalho, MD

CONTACT

+55 (21) 99876059; deisebmc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Organ Transplant Technical Manager

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 20, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 20, 2011

Record last verified: 2011-10

Locations

BR (1)