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Effects of everolimus (Certican) on cardiac hypertrophy and carotid atherosclerosis after kidney transplantation

Effects of Everolimus (Certican) on cardiac hypertrophy and carotid atherosclerosis after kidney transplantation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-26qdtg
Enrollment
Unknown
Registered
2014-01-16
Start date
2012-05-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular hypertrophy and carotid atherosclerosis

Interventions

All patients will receive the same imunossupressive drugs in the beginning of the transplantation: tacrolimo (0,2mg/Kg and frequent readjusts tom maintain a serum level between 20 and 15 ng/ml during
Drug
Other
D02.540.505.810

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Botucatu
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Collaborator

Eligibility

Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: The patient who agree to participate in the study, who have a consent form signed and meet the following criteria: age of 30 years or greater and being a recipient of de novo kidney transplant from a deceased donor or non-HLA identical living donor. At randomization time the patients needs to meet this criteria: creatinine clearance estimated by Cockroft-Gault formula of 40ml/min or greater and proteinuria of 800mg/day or less.

Exclusion criteria

Exclusion criteria: Patients will be excluded of the study if: with painel reactive antibody of 50% or higher, recipients of a second transplant with the first transplant loss for any immunological cause within the first year of transplantation, multi-organ recipient, ABO incompatible donor; non-beating heart donor; donor age of 5 yars or less and donor age of 65 years or higher. At the randomization time, patients will be excluded if: they were on a rejection treatment, if they have history of Baff IIB or higher rejection insult, previous rejection resistant to corticosteroids, presence of subclinical rejection or severe inflammation on protocolar biopsy, presence of total blood cont leucocyte of 2500uL or less, neutrofiles of 1500uL or less, platelets of 75000uL or less, hemoglobin of 6,0g/L or less, liver disease or active infection, positive pregnancy test

Design outcomes

Primary

MeasureTime frame
Reduction of carotid atheromatous plaque thickness assessed by carotid Doppler ultrasound and reduction of left ventricular mass after 6 months and 1 year of the randomization in renal transplanted patients

Secondary

MeasureTime frame
Differences relative to creatinine clearance and number of biopsy-proven acute rejection episodes.

Countries

Brazil

Contacts

Public ContactPaula Garcia

Hospital das Clínicas da Faculdade de Medicina de Botucatu

pauladgarcia@gmail.com551438116547

Outcome results

None listed

Source: REBEC (via WHO ICTRP)