Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

February 28, 2017 updated by: Novartis Pharmaceuticals

A Prospective Multicenter Open-label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients who participated in and completed study CRAD001A2420

Exclusion criteria:

  • Premature study or study treatment discontinuation in CRAD001A2420 study.
  • Acute rejection within the 3 months prior to inclusion

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
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)
Other Names:
  • Myfortic
Drug: Steroids
Active Comparator: Everolimus + Cyclosporine
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: Steroids
Drug: Everolimus + Cyclosporine
Other Names:
  • Neoral
  • Cyclosporine Microemulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
Time Frame: From Baseline to Month 12
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
Time Frame: From Baseline to Month 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12
Time Frame: From Baseline to Month 3, 6, and 12
From Baseline to Month 3, 6, and 12
Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.
Time Frame: Month 6 and 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.
Time Frame: Month 12
Month 12
Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12
Time Frame: From Baseline to Month 3, 6, and 12
Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12
From Baseline to Month 3, 6, and 12
Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12
Time Frame: From Baseline to Month 3, 6, and 12
Change in proteinuria (g/24h) from baseline to M12
From Baseline to Month 3, 6, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Glucose.
Time Frame: From Baseline to Month 1, 3, 6, 9, and 12
Blood chemistry - fasting glycemia (mmol/L)
From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.
Time Frame: From Baseline to Month 1, 3, 6, 9, and 12
Blood chemistry - total cholesterol (mmol/L)
From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.
Time Frame: From Baseline to Month 3, 6, and 12
From Baseline to Month 3, 6, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.
Time Frame: From Baseline to Month 1, 3, 6, 9, and 12
From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).
Time Frame: From Baseline to Month 3, 6, and 12
Blood chemistry - C-reactive Protein (CRP) (mg/L)
From Baseline to Month 3, 6, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 22, 2007

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001AFR06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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