MedDataX Logo

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

NCT ID: NCT00862979

Last Updated: 2018-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-24

Study Completion Date

2017-03-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.

NCT00332839

Renal Transplantation
TERMINATED PHASE4

24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

NCT01169701

Renal Transplant
COMPLETED PHASE4

Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients

NCT00154310

Renal Transplantation
COMPLETED PHASE4

Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

NCT00150046

Heart Transplantation
COMPLETED PHASE3

Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

NCT00170859

Heart Transplantation
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CNI-regimen

CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids

Group Type ACTIVE_COMPARATOR

Everolimus (EVR)

Intervention Type DRUG

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

cyclosporine A (CyA)

Intervention Type DRUG

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

tacrolimus (TAC)

Intervention Type DRUG

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

Corticosteroids

Intervention Type DRUG

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

CNI-free-regimen

CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Group Type EXPERIMENTAL

Everolimus (EVR)

Intervention Type DRUG

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

cyclosporine A (CyA)

Intervention Type DRUG

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

tacrolimus (TAC)

Intervention Type DRUG

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

Enteric coated mycophenolate sodium (EC-MPS)

Intervention Type DRUG

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

mycophenolate mofetil (MMF)

Intervention Type DRUG

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

Corticosteroids

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Everolimus (EVR)

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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Enteric coated mycophenolate sodium (EC-MPS)

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

Intervention Type DRUG

mycophenolate mofetil (MMF)

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

Intervention Type DRUG

Corticosteroids

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Certican, RAD001 Sandimmun Optoral Prograf Myfortic CellCept

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Heart transplantation, 3 months prior to enrollment
* Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
* Sufficient graft function
* Sufficient renal function
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion Criteria

* Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
* Patients who are recipients of A-B-O incompatible transplants
* Cold ischemia time \>6 hours
* Historical or current peak PRA of \> 25% at time of transplantation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Bad Oeynhausen, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Novartis Investigative Site

Regensburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-002671-14

Identifier Type: -

Identifier Source: secondary_id

CRAD001ADE14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.
NCT00170794 COMPLETED PHASE3
Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
NCT00634920 COMPLETED PHASE4
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
NCT00965094 COMPLETED PHASE4
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
NCT01266148 COMPLETED PHASE4
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
NCT01114529 COMPLETED PHASE3
Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up
NCT00596557 COMPLETED PHASE4
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
NCT00903188 UNKNOWN PHASE4
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients
NCT00443937 COMPLETED PHASE4
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
NCT00251004 COMPLETED PHASE3
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
NCT00098007 COMPLETED PHASE3
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
NCT00820911 COMPLETED PHASE2
Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
NCT00956293 TERMINATED PHASE4
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
NCT00154284 COMPLETED PHASE3
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
NCT01025817 COMPLETED PHASE3
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
NCT00170885 COMPLETED PHASE4
Everolimus in de Novo Heart Transplant Recipients
NCT01017029 COMPLETED PHASE4
Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
NCT00170820 COMPLETED PHASE4
A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
NCT00369161 COMPLETED PHASE4
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
NCT00300274 COMPLETED PHASE3
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
NCT01950819 COMPLETED PHASE4
Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
NCT01544491 COMPLETED PHASE3
Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium
NCT01680861 COMPLETED PHASE3
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
NCT00097968 COMPLETED PHASE3
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
NCT00267189 COMPLETED PHASE3
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
NCT03596970 WITHDRAWN PHASE3