Cytomegalovirus Infection Clinical Trial
Official title:
Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate
Verified date | March 2015 |
Source | Hospital do Rim e Hipertensão |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: ANVISABrazil: CEP-UNIFESP |
Study type | Interventional |
Despite the improvement of efficacy results with current immunosuppressive regimens (about
15% of incidence of acute rejection), the security schemes used do not show the same
results.The most worldwide used regime is tacrolimus, mycophenolate and prednisone. Despite
the favorable efficacy results in our population, the use of this combination is associated
with higher incidence of viral infections such as cytomegalovirus, and gastrointestinal
events, two common causes of hospital readmissions after renal transplantation at our
institution.Given this, the investigators propose a study of our own initiative that attends
our local needs: identify the best strategy among the therapeutic options available to
maintain the result of current effectiveness and improve the safety profile for kidney
transplant recipients.This protocol is a prospective, randomized, single center, designed to
compare the safety and efficacy of three immunosuppressive regimens: (1) single dose of
antithymocyte globulin, reduced exposure to tacrolimus, everolimus starting on day 2 after
transplantation and prednisone; ( 2) basiliximab, reduced exposure to tacrolimus, everolimus
starting on day 2 after transplantation and prednisone; (3-control group) basiliximab,
reduced exposure to tacrolimus, mycophenolate and prednisone.Our hypothesis is that a single
dose of antithymocyte globulin or basiliximab induction therapy in combination with low
doses of tacrolimus, everolimus and prednisone results in comparable efficacy observed in
patients receiving tacrolimus / mycophenolate / prednisone, but with a better safety
profile.
To ensure efficacy, the investigators added to the regimes the induction with monoclonal or
polyclonal antibody. To improve the toxicities associated with the current scheme, the
investigators replace the use of mycophenolate by everolimus and the investigators reduced
the dose of tacrolimus.
Patients will be monitored for blood levels of tacrolimus and everolimus to ensure adequate
exposure to immunosuppressive agents.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - low risk adult candidates for first renal transplants from living or deceased donors Exclusion Criteria: - receiving immunosuppressive therapy before transplantation; - have received an investigational medication within the past 30 days; - have a known contraindication to the administration of antithymocyte globulin; - tested positive for human immunodeficiency virus (HIV); - had had cancer (except nonmelanoma skin cancer) within the previous 2 years; - Pregnant women, nursing mothers, and women of childbearing potential who will be not using condoms or oral contraceptives will be excluded; - Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital do rim e Hipertensao | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital do Rim e Hipertensão |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of CMV infection or disease | 1 year | Yes | |
Secondary | incidence of treatment failure defined as a composite end-point of BCAR, graft loss, death, loss to follow up. | 1 year | No |
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