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Completed

NCT Number: NCT00425308

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.

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).

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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

Paris, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus + Cyclosporine

Drug

Other names: Cyclosporine Microemulsion, Neoral

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

Drug

Other names: Myfortic

Steroids

Drug

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

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

    Time frame: Month 6 and 12

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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

  9. Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.

    Time frame: From Baseline to Month 1, 3, 6, 9, and 12

  10. 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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2009
First posted
Jan 22, 2007
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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