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 currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00956293
First received: August 7, 2009
Last updated: January 18, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Sirolimus
Cyclosporine
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Everolimus
Temsirolimus
Basiliximab
U.S. FDA Resources
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: | March 2014 (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
Contacts
| Contact: Novarts Pharmaceuticals | 41613241111 |
Locations
| Germany | |
| Novartis Investigative Site | Recruiting |
| Berlin, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
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: | January 18, 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 May 22, 2013