Study of Everolimus in de Novo Renal Transplant Recipients
Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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MG
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Divinópolis, MG, Brésil, 35500-227
- Hospital São João de Deus/Fundação Geraldo Corrêa
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Ipatinga, MG, Brésil, 35160-158
- Hospital Márcio Cunha/Fundação São Francisco Xavier
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Juiz de Fora, MG, Brésil, 36036-330
- Fundação IMEPEN
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Montes Claros, MG, Brésil, 39400-103
- Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Control
35 patients using Cyclosporin or Tacrolimus (C0=100-200/5-10ng/mL)+ Myfortic® 1440mg/dia + Steroids. Medications will be administered orally, twice a day |
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Comparateur actif: Intervention
35 randomized Patients Converted to Certican® (Everolimus C0=6-10 ng/mL) + Myfortic® 1440mg/day + Steroids. On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended. |
On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in estimated glomerular filtration rate (eGFR)
Délai: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
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The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC).
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4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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graft acute rejection
Délai: 6 and 12 months after conversion
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incidence of acute biopsy-proven rejection and clinical acute rejection (without biopsy), graft loss, death with a functioning graft, and loss of follow up at 6 and 12 months after conversion;
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6 and 12 months after conversion
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Laboratory results and clinical alterations
Délai: 3, 6 and 12 months after conversion
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analyzing the incidence of anemia, thrombocytopenia, leukopenia, gastrointestinal side effects, pneumonitis, oral ulcers, edema, proteinuria, and any other adverse events, as well as the need of drug withdrawal
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3, 6 and 12 months after conversion
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hélady S Pinheiro, MD, PhD, Fundação IMEPEN
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRAD001ABR22T
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