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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01802268
Other study ID # 0468E8-3328
Secondary ID
Status Completed
Phase Phase 4
First received February 22, 2013
Last updated February 27, 2013
Start date February 2008
Est. completion date October 2012

Study information

Verified date February 2013
Source Hospital do Rim e Hipertensão
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date October 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Conversion from Tacrolimus to Sirolimus

Maintenance on tacrolimus


Locations

Country Name City State
Brazil Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil Curitiba Paraná
Brazil Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil Porto Alegre Rio Grande do Sul
Brazil Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil Rio de Janeiro
Brazil 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 Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil São Paulo
Brazil Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil. São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Helio Tedesco Silva Junior Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal Function calculated using the 4 variable MDRD formula 24 months No
Secondary Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification. 24 months No
Secondary Incidence of all treated acute rejections. 24 months No
Secondary Incidence and severity of all tBCAR. 24 months No
Secondary Patient and graft survival. 24 months Yes
Secondary Incidence of treatment discontinuation 24 months Yes
Secondary Incidence of adverse events. 24 months Yes
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