Clinical trial NCT00634920: Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
Official title: A Controlled Randomized Open-label Multicenter Study Evaluating if Early Conversion to Everolimus (Certican) From Cyclosporine (Neoral) in de Novo Renal Transplant Recipients Can Improve Long-term Renal Function and Slow Down the Progression of Chronic Allograft Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Function
Keywords: De novo renal transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy


Eligibility criteria: Inclusion Criteria:

* First or second single renal transplant from deceased or living donor

Exclusion criteria

* Recipient of organs other than a renal transplant
* Present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin
* Severe liver disease
* At the time of randomization 7 weeks after transplantation

In addition to the above criteria the following must be met at time of randomization:

Inclusion Criteria:

* Patients maintained on a triple immunosuppressive regime consisting of cyclosporine, Enteric coated mycophenolate, and corticosteroids
* Patients completed the first 7 weeks without experiencing any rejection

Exclusion Criteria:

* Graft loss
* Low hemoglobin value, low number of white blood cells or platelets
* High cholesterol values
* Proteinuria
* Wound healing problems
* Current severe major local or systemic infection
* Renal insufficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Measured Glomerular Filtration Rate
timeFrame: Month 12
Secondary outcomes:
measure: Measured Glomerular Filtration Rate
timeFrame: Month 36
measure: Calculated Glomerular Filtration Rate
timeFrame: Months 12, 36
measure: Progression of Measured Glomerular Filtration Rate
timeFrame: Week 7, Week 52, Month 36
measure: Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)
timeFrame: Month 12, Month 36
measure: Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)
timeFrame: Months 12, 24, 36
measure: Percentage of Participants With Graft Loss or Death
timeFrame: Months 12, 24, 36
measure: Time to Treatment Failure
timeFrame: Months 12, 24, 36
measure: Percentage of Participants With Treatment Failures
timeFrame: Months 12, 24, 36
measure: Time to First Malignancy
timeFrame: Months 12, 24, 36
measure: Lipid Profile for Apolipoprotein
timeFrame: Months 12, 24, 36
measure: Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides
timeFrame: Months 12, 24, 36
measure: Number of Lipid-lowering Drugs Taken
timeFrame: Months 12, 24, 36
measure: Percentage of Participants on Lipid-lowering Drugs
timeFrame: Months 12, 24, 36
measure: Number of Antihypertensive Drugs Taken
timeFrame: Months 12, 24, 36
measure: Percentage of Participants on Antihypertensive Drugs
timeFrame: Months 12, 24, 36
measure: Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))
timeFrame: Months 12, 24, 36
measure: Percentage of Participants Who Had Donor Specific Antibodies (DSA)
timeFrame: Month 36
measure: Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D
timeFrame: Before randomization, Months 12, 36
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Odense C
country: Denmark
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Malmo
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: