Study Stopped
The trial was terminated early due to slow enrollment. It was determined that the planned sample size of 300 could not be achieved.
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-coated Mycophenolate Sodium and Everolimus in Comparison to Standard Therapy With Enteric-coated Mycophenolate Sodium and Ciclosporin Microemulsion in Stable Renal Transplant Patients
2 other identifiers
interventional
93
1 country
11
Brief Summary
Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2005
Longer than P75 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 31, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
August 28, 2014
CompletedAugust 28, 2014
August 1, 2014
7.3 years
May 31, 2006
March 14, 2014
August 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal Function
The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.
12 months
Secondary Outcomes (6)
Biopsy Proven Acute Rejection, Graft Loss, and Death
12 months
Occurrence of Treatment Failures
12 months
Evolution of Renal Function
Baseline, 12 months
Number of Participants Who Experienced Adverse Events and Death
12 months
Changes in Cardiovascular Risk
Baseline, 12 months
- +1 more secondary outcomes
Study Arms (2)
Calcineurin Inhibitor (CNI) group
ACTIVE COMPARATORParticipants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
Certican group
EXPERIMENTALParticipants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
Interventions
Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).
The dose was based on the participants' blood level of C0h (80-150 ng/ml).
The dose was based on the participants' blood level of C0h (5-10 ng/ml).
The dose was ≥ 720 mg/day.
Corticosteroids were given according to local standard and/or the Investigators' discretion.
Eligibility Criteria
You may qualify if:
- Males or females, aged \> 18 years, Maintenance renal transplant recipients at least 6 months post-transplantation, Patients with a serum creatinine \< 2,5 mg/dL stable for at least three month (according to the investigator), Females capable of becoming pregnant had to have a negative serum pregnancy test within seven days prior to or at baseline, and were required to practice an approved method of birth control for the duration of the study and for a period of six weeks following discontinuation of study medication, even where there had been a history of infertility, Patients receiving Myfortic® (Myfortic dose . 720 mg/d) and Sandimmun® Optoral with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month before baseline;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Novartis Investigative Site
Berlin, 10098, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Cologne, 51109, Germany
Novartis Investigative Site
Erlangen, 91054, Germany
Novartis Investigative Site
Essen, 45122, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Heidelberg, 69115, Germany
Novartis Investigative Site
Heilbronn, 74076, Germany
Novartis Investigative Site
Kaiserslautern, 67655, Germany
Novartis Investigative Site
Kiel, 24105, Germany
Novartis Investigative Site
Münster, 48149, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Adverse Events data were not collected during the Follow-up period.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY DIRECTOR
Novartis
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2006
First Posted
June 2, 2006
Study Start
November 1, 2005
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 28, 2014
Results First Posted
August 28, 2014
Record last verified: 2014-08