Status:
COMPLETED
Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
Lead Sponsor:
Helio Tedesco Silva Junior
Collaborating Sponsors:
Pfizer
Conditions:
Kidney Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi assoc...
Eligibility Criteria
Inclusion
- patients older than 18 years,
- recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
- patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
- all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.
Exclusion
- patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,
- patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
- patients with previous history of malignancy,
- patients with significant hematological or metabolic laboratorial abnormalities.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01802268
Start Date
February 1 2008
End Date
October 1 2012
Last Update
March 1 2013
Active Locations (6)
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1
Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
Curitiba, Paraná, Brazil
2
Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
3
Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
4
Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
São Jose Do Rio Preto, São Paulo, Brazil, 04038