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

Immunosuppression Clinical Trial

Official title:

A Prospective, Open-label, Controlled, Randomized Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After 90 to 150 Days After Kidney Transplantation in Adults, Maintaining Corticosteroid and Mycophenolate Sodium Compared to Patients Who Will Maintain the Use of Calcineurin Inhibitor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01455649
• Other study ID #: CRAD001ABR17T
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 11, 2011
• Last updated: October 19, 2011
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: October 2011
• Source: Hospital Federal de Bonsucesso
• Contact: Deise BM Carvalho, MD
• Phone: +55 (21) 99876059
• Email: deisebmc[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Immunosuppression
• Kidney Transplant

Intervention

Drug:
• Everolimus
Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
• calcineurin inhibitor
Group will maintain their initial immunosuppression therapy with calcineurin inhibitor

Locations

Country	Name	City	State
Brazil	Hospital federal de Bonsucesso	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Deise de Boni Monteiro de Carvalho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants with Adverse Events	The secondary objective is to demonstrate the safety by comparing rejection episodes, graft loss, infection, cancer and death in the control group	baseline and two years	Yes