Clinical trial NCT01802268: Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
Official title: Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Keywords: sirolimus
tacrolimus
early conversion
Lead sponsor: Hospital do Rim e Hipertensão
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-03-01
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.

This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Renal Function calculated using the 4 variable MDRD formula
timeFrame: 24 months
Secondary outcomes:
measure: Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.
timeFrame: 24 months
measure: Incidence of all treated acute rejections.
timeFrame: 24 months
measure: Incidence and severity of all tBCAR.
timeFrame: 24 months
measure: Patient and graft survival.
timeFrame: 24 months
measure: Incidence of treatment discontinuation
timeFrame: 24 months
measure: Incidence of adverse events.
timeFrame: 24 months
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
state: Paraná
city: Porto Alegre
country: Brazil
facility: Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
state: Rio Grande do Sul
city: São Jose do Rio Preto
country: Brazil
facility: Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
city: São Paulo
country: Brazil
facility: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
city: São Paulo
country: Brazil
facility: Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.
Study officials:
affiliation: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
name: Helio T. Silva Junior, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
name: Claudia R. Felipe, PhD
role: STUDY_CHAIR
affiliation: Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
name: Valter D. Garcia, PhD
role: STUDY_CHAIR
affiliation: Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil
name: Elias D. Neto, PhD
role: STUDY_CHAIR
affiliation: Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
name: Mario A. Filho, PhD
role: STUDY_CHAIR
affiliation: Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
name: Fabiana LC Cortieri, PhD
role: STUDY_CHAIR
affiliation: Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
name: Deise BM Carvalho, PhD
role: STUDY_CHAIR
affiliation: Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
name: Jose OM Pestana, PhD
role: STUDY_DIRECTOR
References: