Phase 4 N=341 Randomized Treatment

Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients

Renal Function

Bottom Line

View on ClinicalTrials.gov: NCT00634920 ↗

Enrolled (actual)

341

Serious AEs

67.8%

Results posted

Aug 2014

Primary outcome: Primary: Measured Glomerular Filtration Rate — 51.5; 47.8 mL/min/1.73m^2

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: everolimus (Drug); cyclosporine A (Drug); Enteric Coated Mycophenolate Sodium (EC-MPS) (Drug); corticosteroids (Drug); Basiliximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Measured Glomerular Filtration Rate	48.2; 46.1	—
SECONDARY Measured Glomerular Filtration Rate	48.2; 46.1	—
SECONDARY Calculated Glomerular Filtration Rate	65.0; 60.1; 59.4; 57.4; 45.4; 45.6	—
SECONDARY Progression of Measured Glomerular Filtration Rate	46.3; 47.8; 51.5; 47.8; 5.6; 0.0	—
SECONDARY Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)	1.0; 1.0; 59.0; 64.0	—
SECONDARY Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)	19.6; 4.4; 10.9; 0.0; 2.2; 2.2	—
SECONDARY Percentage of Participants With Graft Loss or Death	0.0; 0.0; 100.0; 100.0; 1.1; 1.1	—
SECONDARY Time to Treatment Failure	972.7; 959.5	—
SECONDARY Percentage of Participants With Treatment Failures	100.0; 100.0; 0.0; 0.0; 98.8; 98.8	—
SECONDARY Time to First Malignancy	35.5; 35.1	—
SECONDARY Lipid Profile for Apolipoprotein	1.59; 1.46; 1.55; 1.36; 1.70; 1.56	—
SECONDARY Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides	1.486; 1.419; 1.477; 1.409; 1.495; 1.529	—
SECONDARY Number of Lipid-lowering Drugs Taken	0.9; 0.8; 1.0; 0.9; 0.9; 0.8	—
SECONDARY Percentage of Participants on Lipid-lowering Drugs	75.0; 60.0; 78.0; 65.0; 73.0; 63.0	—
SECONDARY Number of Antihypertensive Drugs Taken	2.5; 2.5; 2.5; 2.4; 2.0; 2.2	—
SECONDARY Percentage of Participants on Antihypertensive Drugs	9.2; 3.3; 90.8; 96.7; 4.2; 5.3	—
SECONDARY Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))	17.31; 11.27; 62.83; 24.55; 78.78; 80.73	—
SECONDARY Percentage of Participants Who Had Donor Specific Antibodies (DSA)	7.0; 9.0; 78.0; 70.0; 15.0; 21.0	—
SECONDARY Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D	0.8430; 0.8693; 0.8155; 0.8470; 0.8285; 0.8422	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00634920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.