Clinical trial NCT00956293: Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 207
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method
timeFrame: Month 6
Secondary outcomes:
measure: Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method
timeFrame: Month 6
measure: Renal Function by Serum Creatinine
timeFrame: Months 6, 12, 24, 36, 48 and 60
measure: Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death
timeFrame: Months 6, 12, 24, 36, 48 and 60
measure: Occurrence of Treatment Failures
timeFrame: Month 6
measure: Evolution of Renal Function (Creatinine Slope)
timeFrame: Week 7, Month 6
measure: CD25 Saturation on Lymphocytes
timeFrame: Month 6
measure: Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death
timeFrame: Months 6, 12, 24, 36, 48 and 60
measure: Renal Function by GFR Over Time
timeFrame: Months 12, 24, 36, 48 and 60
measure: Renal Function by Proteinuria
timeFrame: Months12, 24, 36, 48 and 60
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
city: Koeln-Merheim
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Brakemeier S, Arns W, Lehner F, Witzke O, Vonend O, Sommerer C, Muhlfeld A, Rath T, Schuhmann R, Zukunft B, Kroeger I, Porstner M, Budde K. Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: Results of a prospective randomized multicenter study (SENATOR). PLoS One. 2019 Sep 19;14(9):e0222730. doi: 10.1371/journal.pone.0222730. eCollection 2019.