NCT00425308

Brief Summary

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 19, 2011

Completed
Last Updated

March 30, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

January 19, 2007

Results QC Date

January 6, 2011

Last Update Submit

February 28, 2017

Conditions

Renal Transplantation

Keywords

Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy

Outcome Measures

Primary Outcomes (2)

  • Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.

    Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

    From Baseline to Month 12

  • Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial

    Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

    From Baseline to Month 12

Secondary Outcomes (10)

  • Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12

    From Baseline to Month 3, 6, and 12

  • Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.

    Month 6 and 12

  • Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.

    Month 12

  • Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12

    From Baseline to Month 3, 6, and 12

  • Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12

    From Baseline to Month 3, 6, and 12

  • +5 more secondary outcomes

Study Arms (2)

Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

ACTIVE COMPARATOR

Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)Drug: Steroids

Everolimus + Cyclosporine

ACTIVE COMPARATOR

Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids

Drug: Everolimus + CyclosporineDrug: Steroids

Interventions

Everolimus + CyclosporineDRUG
Also known as: Cyclosporine Microemulsion, Neoral
Everolimus + Cyclosporine
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)DRUG
Also known as: Myfortic
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
SteroidsDRUG
Everolimus + CyclosporineEverolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who participated in and completed study CRAD001A2420

You may not qualify if:

  • Premature study or study treatment discontinuation in CRAD001A2420 study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Paris, France

Location

MeSH Terms

Interventions

EverolimusCyclosporineMycophenolic AcidSteroids

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsFused-Ring Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

October 1, 2006

Primary Completion

May 1, 2009

Last Updated

March 30, 2017

Results First Posted

April 19, 2011

Record last verified: 2017-02

Locations

FR(1)