Study of Everolimus in de Novo Renal Transplant Recipients

Not Applicable

Terminated

• Conditions: End Stage Renal Failure With Renal Transplant
• Interventions: Drug: Everolimus

• Registration Number: NCT01609673
• Lead Sponsor: Helady Pinheiro, MD, PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-01
• Study Start: 2013-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Everolimus	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.

Primary Outcome Measures

Name	Time	Method
Change in estimated glomerular filtration rate (eGFR)	4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus	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).

Secondary Outcome Measures

Name	Time	Method
graft acute rejection	6 and 12 months after conversion	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;
Laboratory results and clinical alterations	3, 6 and 12 months after conversion	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

Trial Locations

Locations (4)

Fundação IMEPEN; 🇧🇷 Juiz de Fora, MG, Brazil

Hospital São João de Deus/Fundação Geraldo Corrêa; 🇧🇷 Divinópolis, MG, Brazil

Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês; 🇧🇷 Montes Claros, MG, Brazil

Hospital Márcio Cunha/Fundação São Francisco Xavier; 🇧🇷 Ipatinga, MG, Brazil