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A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01608412
Recruitment Status : Unknown
Verified August 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : May 31, 2012
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 31, 2012
Last Update Posted Date May 31, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
Evaluate cumulative patient and graft survival at 12 months post conversion [ Time Frame: one year ]
Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
Evaluation of estimated glomerular filtration rate 12 months post-conversion [ Time Frame: one year ]
- To assess the efficacy of conversion from tacrolimus to everolimus 12 months post-conversion by measuring the estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) equation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus
Official Title  ICMJE An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.
Brief Summary

The study hypotheses to be tested in this study are:

  • Conversion to everolimus at 3 months post-transplantation is safe and effective;
  • Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;
  • Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Kidney Transplant Recipients
Intervention  ICMJE
  • Drug: Tacrolimus
    TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred
  • Drug: Everolimus
    Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred
Study Arms  ICMJE
  • Active Comparator: Tacrolimus

    The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy.

    Intervention arm: Tacrolimus

    Intervention: Drug: Tacrolimus
  • Active Comparator: Everolimus

    The subjects included in the study will be clinically followed up for at least 12 months. The patients will be selected at 3 months post-transplant according to inclusion and exclusion criteria and randomized in a 1:1 ratio for conversion to everolimus or maintenance of tacrolimus therapy.

    Intervention arm: Everolimus

    Intervention: Drug: Everolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 30, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing their first living- or deceased-donor kidney transplant who maintain a functioning graft 3 months post-transplant;
  • Older than 18 years;
  • Panel-reactive antibodies lower than 20%;
  • Baseline immunosuppression with tacrolimus, mycophenolate sodium (MPS) and prednisone at randomization at 3 months.

Exclusion Criteria:

  • eGFR < 35 mL/min at randomization;
  • Urine protein-to-creatinine ratio > 0.8 at randomization;
  • Episode of acute rejection with Banff histological classification > 1A in the first 3 months post-transplant;
  • Cholesterol > 350 mg/dL or triglycerides > 400 mg/dL with therapy at randomization;
  • Active infection at randomization;
  • Chronic liver disease;
  • Refusal to participate in the study;
  • Contraindications to kidney biopsy;
  • Biopsy findings at 3 months post-transplant including borderline rejection, cellular rejection or antibody-mediated rejection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01608412
Other Study ID Numbers  ICMJE CRAD001ABR19T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luiz Felipe S. Gonçalves, MD HCPA
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date August 2011

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