Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program (Senator)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00956293
First received: August 7, 2009
Last updated: October 16, 2013
Last verified: October 2013

August 7, 2009
October 16, 2013
July 2009
December 2017   (final data collection date for primary outcome measure)
renal function assessed by glomerular filtration rate - Cockcroft-Gault method [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00956293 on ClinicalTrials.gov Archive Site
  • renal function by GFR - MDRD and Nankivell method [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • renal function by serum creatinine [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • efficacy (biopsy proven acute rejection, graft loss, death) [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • occurrence of treatment failures, (biopsy proven acute rejection, graft loss, death, loss to follow up and discontinuations due to lack of efficacy or toxicity or conversion to another regimen) [ Time Frame: up to or at Month 6 ] [ Designated as safety issue: No ]
  • evolution of renal function (creatinine slope) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
6-month, Open-label, Randomized, Multicenter, Prospective, Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplantation
  • Drug: Everolimus, Basiliximab
    Everolimus, Basiliximab
  • Drug: Enteric Coated Mycophenolate Sodium, Cyclosporine A
    Enteric Coated Mycophenolate Sodium, Cyclosporine A
  • Experimental: 1
    Intervention: Drug: Everolimus, Basiliximab
  • Active Comparator: 2
    Intervention: Drug: Enteric Coated Mycophenolate Sodium, Cyclosporine A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
Not Provided
December 2017   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients receiving a primary kidney from a donor aged > 65 years
  • In the Eurotransplant Senior Program
  • Recipients of de novo cadaveric kidney transplants

Exclusion criteria:

  • Multi-organ recipients (e.g., kidney and pancreas)
  • Patients receiving a kidney from a non-heart beating donor
  • Patients who are recipients of A-B-O incompatible transplants
  • Patients with already existing antibodies against the HLA-type of the receiving transplant
  • Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
  • Patients with thrombocytopenia, with an absolute neutrophil count of < 1,500/mm³ or leucopenia or hemoglobin < 6 g/dL
  • Patients who are HIV, HCV RNA, or Hepatitis B surface antigen positive
  • Evidence of severe liver disease
  • Females at randomization who will be not considered post-menopausal

Other protocol-defined inclusion/exclusion criteria may apply

Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00956293
CRAD001ADE19, EudraCT-NO. 2008-005109-20
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2013

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