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

This study is currently recruiting participants.
Verified August 2011 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01608412
First received: May 8, 2012
Last updated: May 30, 2012
Last verified: August 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Kidney Transplant Recipients
 Drug: Tacrolimus
Drug: Everolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Evaluate cumulative patient and graft survival at 12 months post conversion [ Time Frame: one year ] [ Designated as safety issue: No ]
    Patient and graft survival will be evaluated one year after randomization by Kaplan-Meier analysis


Secondary Outcome Measures:
  • Evaluation of estimated glomerular filtration rate 12 months post-conversion [ Time Frame: one year ] [ Designated as safety issue: No ]
    - 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


Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 Drug: Tacrolimus
TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred
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

 Drug: Everolimus
Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608412

Contacts
Contact: Luiz Felipe S. Gonçalves, MD lfgoncalves@hcpa.ufrgs.br
Contact: Nisséia Jahn, RN nisseia@yahoo.com.br

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Luiz Felipe S. Gonçalves, MD HCPA
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01608412     History of Changes
Other Study ID Numbers: CRAD001ABR19T
Study First Received: May 8, 2012
Last Updated: May 30, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital de Clinicas de Porto Alegre:
renal transplantation
everolimus
tacrolimus
molecular evaluation

Additional relevant MeSH terms:
Everolimus
Sirolimus
Tacrolimus
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 19, 2013