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
  Purpose

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


Condition Intervention Phase
Renal Transplantation
Drug: Everolimus (RAD001)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • • 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:
  • 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,

Estimated Enrollment: 237
Study Start Date: November 2001
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531063

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00531063     History of Changes
Other Study ID Numbers: CRAD001A2306E1
Study First Received: September 17, 2007
Last Updated: November 1, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Novartis:
Renal transplantation, everolimus, Immunosuppressants

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

ClinicalTrials.gov processed this record on April 16, 2014