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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

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ClinicalTrials.gov Identifier: NCT00531063
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: Everolimus (RAD001) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : November 2001
Actual Primary Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  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,


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531063


Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00531063     History of Changes
Other Study ID Numbers: CRAD001A2306E1
First Posted: September 18, 2007    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal transplantation, everolimus, Immunosuppressants

Additional relevant MeSH terms:
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents