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
  Purpose

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.


Condition Intervention Phase
Renal Transplantation
Drug: Everolimus, Basiliximab
Drug: Enteric Coated Mycophenolate Sodium, Cyclosporine A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • renal function assessed by glomerular filtration rate - Cockcroft-Gault method [ Time Frame: at month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: July 2009
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Everolimus, Basiliximab
Everolimus, Basiliximab
Active Comparator: 2 Drug: Enteric Coated Mycophenolate Sodium, Cyclosporine A
Enteric Coated Mycophenolate Sodium, Cyclosporine A

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956293

Locations
Germany
Novartis Investigative Site
Berlin, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00956293     History of Changes
Other Study ID Numbers: CRAD001ADE19, EudraCT-NO. 2008-005109-20
Study First Received: August 7, 2009
Last Updated: October 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Everolimus
Sirolimus
Basiliximab
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014