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.
1 other identifier
interventional
237
1 country
1
Brief Summary
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 17, 2007
CompletedFirst Posted
Study publicly available on registry
September 18, 2007
CompletedNovember 2, 2011
November 1, 2011
3.8 years
September 17, 2007
November 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• 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
Secondary Outcomes (1)
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,
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis
Basel, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2007
First Posted
September 18, 2007
Study Start
November 1, 2001
Primary Completion
August 1, 2005
Last Updated
November 2, 2011
Record last verified: 2011-11