Efficacy Study of Everolimus on Renal Function in Heart T... | NCT00716573

Studies
Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure

NCT00716573

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Jun 20, 2017Actual

Enrollment

120Actual

Phase

Phase 4

Conditions

Cardiac Transplantation
Chronic Renal Insufficiency

Interventions

everolimus

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2008Actual

Primary Completion Date

Apr 17, 2014Actual

Completion Date

Apr 17, 2014Actual

First Submitted Date

Jul 15, 2008

First Submission Date that Met QC Criteria

Jul 15, 2008

First Posted Date

Jul 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials.

This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on :

Renal function improvement
Vasculopathy and major cardiac event reduction
Maintenance of immunosuppressive efficacy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule	Drug: everolimus
2	No Intervention	Maintain of their current immunosuppressive therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
everolimus	Drug	0,75 mg bid, 24 months	1	Certican

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the benefit of everolimus introduction on renal function at 24 months		24 months
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female cardiac recipients over 18 years old
First or second heart transplant, more than one year following surgery
Patients with renal failure assessed by cGFR 30 to 60 ml/min/1,73m² calculated by MDRD4 formula
Patients volunteer to participate in the study, with a written informed consent signed
Affiliation to a national health insurance program

Exclusion Criteria:

Current CNI-free immunosuppressive regimen
Patients currently or previously treated with a mTOR inhibitor any time prior randomization
Patients who are recipients for a multiple solid organ transplant
Treated acute rejection episode within three months prior randomization
Congestive heart failure (NYHA class III or IV) and/or VEF < 30 % and/or patient waiting for a re-transplantation
Scheduled surgical intervention
Platelet count < 50 G/l
Severe hepatic insufficiency (SGPT and/or SGOT > 3N)
Major lipidic profile abnormalities (total cholesterol > 3g/l and/or TG > 5g/l)
Proteinuria/creatinuria > 0,08 g/mmol
Severe renal failure attested by cGFR < 30 ml/min/1.73m² (MDRD4)
History of Hypersensitivity to everolimus, sirolimus or excipients
History of Hypersensitivity to macrolides
Pregnancy and breast feeding
Childbearing age women without efficient contraception
Law protected patients
Patients in emergency unable to express their consent
History of Hypersensitivity to cyclosporine or St-John's wort, stiripentol, bosentan, rosuvastatin
History of Hypersensitivity to tacrolimus, macrolides or excipients
History of Hypersensitivity to azathioprine
History of Hypersensitivity to mycophénolate mofetil or excipients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals