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This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00531063
First received: September 17, 2007
Last updated: November 1, 2011
Last verified: November 2011
History of Changes

September 17, 2007
November 1, 2011
November 2001
August 2005   (final data collection date for primary outcome measure)
• To assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, biopsy-proven chronic allograft nephropathy, retransplantation or dialysis up to 36 months
Same as current
Complete list of historical versions of study NCT00531063 on ClinicalTrials.gov Archive Site
To quantify the incidence of biopsy-proven acute rejection episodes, graft loss, death or lost to follow-up at 6, 12, 24 and 36 months in both groups. To assess the incidence of graft loss, death, biopsy-proven acute rejection,
Same as current
Not Provided
Not Provided
 
This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
A 2-year Extension to a 1-year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus With Steroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.

This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Renal Transplantation
Drug: Everolimus (RAD001)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
Not Provided
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are receiving study medication at Month 12 of the one-year study (CRAD001A2306) and sign a new Informed Consent to extend the treatment and observation period beyond Month 12.
  • Females patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
  • Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies
  • Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.

Exclusion Criteria:

  • Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 RAD001A2306)
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00531063
CRAD001A2306E1
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP