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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Hospital Federal de Bonsucesso.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Deise de Boni Monteiro de Carvalho, Hospital Federal de Bonsucesso
ClinicalTrials.gov Identifier:
NCT01455649
First received: October 11, 2011
Last updated: October 19, 2011
Last verified: October 2011

October 11, 2011
October 19, 2011
November 2011
November 2013   (final data collection date for primary outcome measure)
Change from Baseline in Creatinine Clearance at 24 months [ Time Frame: baseline and two years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01455649 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events [ Time Frame: baseline and two years ] [ Designated as safety issue: Yes ]
The secondary objective is to demonstrate the safety by comparing rejection episodes, graft loss, infection, cancer and death in the control group
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Transplant
  • Immunosuppression
  • Drug: Everolimus
    Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
    Other Name: Certican
  • Drug: calcineurin inhibitor
    Group will maintain their initial immunosuppression therapy with calcineurin inhibitor
    Other Name: Tacrolimus, Cyclosporin, NeoOral, Prograf
  • Experimental: Everolimus
    Intervention: Drug: Everolimus
  • Active Comparator: calcineurin inhibitor
    Intervention: Drug: calcineurin inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Deise BM Carvalho, MD +55 (21) 99876059 deisebmc@gmail.com
Brazil
 
NCT01455649
CRAD001ABR17T
No
Deise de Boni Monteiro de Carvalho, Hospital Federal de Bonsucesso
Deise de Boni Monteiro de Carvalho
Not Provided
Study Chair: 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
Hospital Federal de Bonsucesso
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP