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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 22, 2014