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

This study is not yet open for participant recruitment.
Verified October 2011 by Hospital Federal de Bonsucesso
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
History of Changes
  Purpose

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 Intervention Phase
Kidney Transplant
Immunosuppression
 Drug: Everolimus
Drug: calcineurin inhibitor
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Federal de Bonsucesso:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 11, 2011
Last Updated: October 19, 2011
Health Authority: Brazil: National Health Surveillance Agency
Brazil: Ministry of Health

Keywords provided by Hospital Federal de Bonsucesso:
Kidney
Transplant
Immunosuppression
Everolimus
Graft function

Additional relevant MeSH terms:
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013