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A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

NCT00862979 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2018-08-07

Study results available
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Summary

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

Conditions

  • Heart Transplantation

Interventions

DRUG

Everolimus (EVR)

Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL)

DRUG

cyclosporine A (CyA)

10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only

DRUG

tacrolimus (TAC)

0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only

DRUG

Enteric coated mycophenolate sodium (EC-MPS)

180 mg or 360 mg tablet dosed 1440-2280 mg per day

DRUG

mycophenolate mofetil (MMF)

250 mg or 500 mg tablets with a dose of 1500-3000 mg per day

DRUG

Corticosteroids

according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-24
Primary Completion
2017-03-06
Completion
2017-03-06

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00862979 on ClinicalTrials.gov