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 has been terminated.
(The study was terminated because the required sample size of 240-260 de novo senior renal transplant patients was not achieved within a reasonable time.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00956293
First received: August 7, 2009
Last updated: May 23, 2014
Last verified: May 2014

August 7, 2009
May 23, 2014
July 2009
March 2013   (final data collection date for primary outcome measure)
Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
The study was terminated prematurely and not powered for efficacy.
renal function assessed by glomerular filtration rate - Cockcroft-Gault method [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956293 on ClinicalTrials.gov Archive Site
  • Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    The study was terminated prematurely and not powered for efficacy.
  • Renal Function by Serum Creatinine [ Time Frame: Months 6, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
    The study was terminated prematurely and not powered for efficacy.
  • Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death [ Time Frame: Months 6, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
    The study was terminated prematurely and not powered for efficacy.
  • Occurrence of Treatment Failures [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    The study was terminated prematurely and not powered for efficacy.
  • Evolution of Renal Function (Creatinine Slope) [ Time Frame: Week 7, Month 6 ] [ Designated as safety issue: No ]
    The study was terminated prematurely and not powered for efficacy.
  • CD25 Saturation on Lymphocytes [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death [ Time Frame: Months 6, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: Yes ]
    Participants with adverse events (serious plus non-serious), serious adverse events and death were reported.
  • Renal Function by GFR Over Time [ Time Frame: Months 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Renal Function by Proteinuria [ Time Frame: Months12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • 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 ]
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: Basiliximab
    On day 0, 2 hours prior to transplant and day 4 post-transplant, 20 mg x2 were given to all participants. Post randomization, 20mg at weeks 7 and 12 were given to the Everolimus group.
    Other Name: Simulect
  • Drug: Enteric Coated Mycophenolic Acid (MPA)
    A loading dose regimen of 2880 mg/day during weeks 1 and 2 (pre-randomization) were given. During weeks 3 - 6 (pre-randomization), 2160 mg/day were given and during weeks 7 - 24, 1440 mg/day were given if tolerated. Dose reductions due to side effects were possible.
    Other Name: Myfortic
  • Drug: RAD001
    Upon randomization, 3 mg (od) on Day 1, and 3 mg (1.5 mg every 12 hours) on Day 2 was given. Afterwards, the dosage was based on blood trough level (5 - 10 ng/mL).
    Other Name: RAD001, Certcian
  • Drug: Cyclosporin A (CsA)
    Dosage was based according to blood level
    Other Name: Sandimmun Optoral
  • Drug: Corticosteroids
    Dosage was administered according to local standards and administration was optional as per clinical need and the Investigators' discretion. Steroid withdrawal occurred after week 2 (pre-randomization).
  • Active Comparator: Control group
    During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
    Interventions:
    • Drug: Basiliximab
    • Drug: Enteric Coated Mycophenolic Acid (MPA)
    • Drug: Cyclosporin A (CsA)
    • Drug: Corticosteroids
  • Experimental: Everolimus group
    During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
    Interventions:
    • Drug: Basiliximab
    • Drug: Enteric Coated Mycophenolic Acid (MPA)
    • Drug: RAD001
    • Drug: Cyclosporin A (CsA)
    • Drug: Corticosteroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
207
March 2013
March 2013   (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, 2008-005109-20
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

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