Clinical trial NCT01609673: Study of Everolimus in de Novo Renal Transplant Recipients
Official title: Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Failure With Renal Transplant
Keywords: Immunosuppression
Chronic Kidney Disease
Renal Transplant
Lead sponsor: Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2012-06-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.

The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.


Eligibility criteria: Inclusion Criteria:

* Renal transplant patients
* Age between 18 and 85 years
* Recipients of living or deceased donors
* Donor under the age of 85 years
* Panel Reactivity Antibodies (PRA) over or equal to 30%
* 4-5 months post-transplant
* CNI-based immunosuppressive regimen
* Stable graft function (creatinine lower than 2.0 mg/dl)
* No currently acute rejection
* Proteinuria lower than 800mg/d
* No laboratory or physical clinically significant signs presented for the last 2 months before screening.

Exclusion Criteria:

* Recipient of multiple organs
* Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis
* Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL)
* Patients with eGFR lower than 40 ml/min/1.73m2
* Evidence of acute rejection within 2 months before screening
* Thrombocytopenia (lower than 75,000/mm3)
* Neutropenia (lower than 1,500/mm3)
* Leukocytopenia (lower than 2500/mm3)
* Anemia (hemoglobin lower than 6.0g/dL)
* Severe liver disease (including transaminases or bilirubin equal or over 3 times normal)
* Proteinuria over 800mg/dL
* Systemic infection or pneumonia (active infection)
* Positive for Hepatitis B, Hepatitis C or HIV.

Primary outcomes:
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
Secondary outcomes:
measure: graft acute rejection
timeFrame: 6 and 12 months after conversion
measure: Laboratory results and clinical alterations
timeFrame: 3, 6 and 12 months after conversion
Other outcomes:
Locations:
city: Divinópolis
country: Brazil
facility: Hospital São João de Deus/Fundação Geraldo Corrêa
state: MG
city: Ipatinga
country: Brazil
facility: Hospital Márcio Cunha/Fundação São Francisco Xavier
state: MG
city: Juiz de Fora
country: Brazil
facility: Fundação IMEPEN
state: MG
city: Montes Claros
country: Brazil
facility: Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês
state: MG
Study officials:
affiliation: Fundação IMEPEN
name: Hélady S Pinheiro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: