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

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ClinicalTrials.gov Identifier: NCT01455649
Recruitment Status : Unknown
Verified October 2011 by Deise de Boni Monteiro de Carvalho, Hospital Federal de Bonsucesso.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2011
Last Update Posted : October 20, 2011
Sponsor:
Information provided by (Responsible Party):
Deise de Boni Monteiro de Carvalho, Hospital Federal de Bonsucesso

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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Immunosuppression Drug: Everolimus Drug: calcineurin inhibitor Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Everolimus Drug: Everolimus
Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
Other Name: Certican

Active Comparator: calcineurin inhibitor Drug: calcineurin inhibitor
Group will maintain their initial immunosuppression therapy with calcineurin inhibitor
Other Name: Tacrolimus, Cyclosporin, NeoOral, Prograf




Primary Outcome Measures :
  1. Change from Baseline in Creatinine Clearance at 24 months [ Time Frame: baseline and two years ]
    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.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: baseline and two years ]
    The secondary objective is to demonstrate the safety by comparing rejection episodes, graft loss, infection, cancer and death in the control group



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455649


Contacts
Contact: Deise BM Carvalho, MD +55 (21) 99876059 deisebmc@gmail.com

Locations
Brazil
Hospital federal de Bonsucesso Not yet recruiting
Rio de Janeiro, Brazil, 21041-030
Sponsors and Collaborators
Deise de Boni Monteiro de Carvalho
Investigators
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

Responsible Party: Deise de Boni Monteiro de Carvalho, Organ Transplant Technical Manager, Hospital Federal de Bonsucesso
ClinicalTrials.gov Identifier: NCT01455649     History of Changes
Other Study ID Numbers: CRAD001ABR17T
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011

Keywords provided by Deise de Boni Monteiro de Carvalho, Hospital Federal de Bonsucesso:
Kidney
Transplant
Immunosuppression
Everolimus
Graft function

Additional relevant MeSH terms:
Everolimus
Sirolimus
Calcineurin Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action