Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program (Senator)
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| ClinicalTrials.gov Identifier: NCT00956293 |
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Recruitment Status :
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.)
First Posted : August 11, 2009
Results First Posted : May 12, 2014
Last Update Posted : June 6, 2014
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Transplantation | Drug: Basiliximab Drug: Enteric Coated Mycophenolic Acid (MPA) Drug: RAD001 Drug: Cyclosporin A (CsA) Drug: Corticosteroids | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 207 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | March 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Everolimus
| Arm | Intervention/treatment |
|---|---|
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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.
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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: 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). |
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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.
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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). |
Primary Outcome Measures :
- Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method [ Time Frame: Month 6 ]The study was terminated prematurely and not powered for efficacy.
Secondary Outcome Measures :
- Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method [ Time Frame: Month 6 ]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 ]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 ]The study was terminated prematurely and not powered for efficacy.
- Occurrence of Treatment Failures [ Time Frame: Month 6 ]The study was terminated prematurely and not powered for efficacy.
- Evolution of Renal Function (Creatinine Slope) [ Time Frame: Week 7, Month 6 ]The study was terminated prematurely and not powered for efficacy.
- CD25 Saturation on Lymphocytes [ Time Frame: Month 6 ]
- Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death [ Time Frame: Months 6, 12, 24, 36, 48 and 60 ]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 ]
- Renal Function by Proteinuria [ Time Frame: Months12, 24, 36, 48 and 60 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956293
Locations
| Germany | |
| Novartis Investigative Site | |
| Aachen, Germany, 52074 | |
| Novartis Investigative Site | |
| Berlin, Germany, 10117 | |
| Novartis Investigative Site | |
| Duesseldorf, Germany, 40225 | |
| Novartis Investigative Site | |
| Essen, Germany, 45147 | |
| Novartis Investigative Site | |
| Hannover, Germany, 30625 | |
| Novartis Investigative Site | |
| Heidelberg, Germany, 69120 | |
| Novartis Investigative Site | |
| Kaiserslautern, Germany, 67655 | |
| Novartis Investigative Site | |
| Koeln-Merheim, Germany, 51109 | |
| Novartis Investigative Site | |
| München, Germany, 81377 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00956293 |
| Other Study ID Numbers: |
CRAD001ADE19 EudraCT-NO. 2008-005109-20 2008-005109-20 |
| First Posted: | August 11, 2009 Key Record Dates |
| Results First Posted: | May 12, 2014 |
| Last Update Posted: | June 6, 2014 |
| Last Verified: | May 2014 |
Additional relevant MeSH terms:
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Cyclosporine Mycophenolic Acid Everolimus Cyclosporins Basiliximab Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors Antineoplastic Agents Antibiotics, Antineoplastic Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |