SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00371826

Purpose

The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will be compared to a third control group, who will receive treatment consisting of cyclosporine micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.

Condition	Intervention	Phase
Renal Transplantation	Drug: Everolimus (RAD001)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Open-Label, Controlled Multicenter Trial to Assess the Efficacy and Safety of an Induction Regimen of Cyclosporine Micro Emulsion, Enteric-Coated Mycophenolate Sodium (EC-MPS) and Corticosteroids, Followed by Administration of Everolimus and Enteric-Coated Mycophenolate Sodium (EC-MPS), With Either the Withdrawal of Cyclosporine Micro Emulsion or Corticosteroids in de Novo Kidney Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin Everolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Kidney function (measured by eGFR using the Nankivell method) 12 months after transplant

Secondary Outcome Measures:

Incidence of Biopsy Proven Acute rejection (BPAR) at month 12
Histology (Chronic Allograft Nephropathy, subclinical Acute Rejection) at Month 12
Proteinuria at month 12
Patient graft survival at month 12
Incidence of wound problems
Prevalence of PTDM ( post transplant diabetes mellitus) at month 12
Effect of cardiovascular health measured by serum lipids, blood pressure and cardiovascular events
Incidence of anemia, leucopenia, thrombocytopenia and erythropoietin usage
Quality of life assessment at month 12
Effect of healthcare resource utilization ( hospital events) and employment status
Influence of parameters on safety and efficacy outcomes

Estimated Enrollment:	177
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion criteria

Males and females aged 18-65 years inclusive.
First time recipients of cadaveric, living unrelated or living related donor kidney transplants.
Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

Patients who are recipients of multiple organ transplants, including more than one kidney, kidney and pancreas, or previous transplant with any organ other than kidney.
Patients at high immunological risk of graft loss, indicated by peak PRA >50% or loss of a previous renal allograft within the first 6 months of transplantation due to acute rejection.
Patients who have received an investigational drug within 4 weeks prior to the screening visit.
Presence of any severe allergy or hypersensitivity to drugs similar to everolimus (e.g. antibiotics such as Clindamycin)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371826

Contacts

Contact: novartis

41 61 324 1111

Locations

Australia
Royal Prince Alfred Hospital	Recruiting
NSW, Australia
Contact: novartis 41 61 324 1111
Monash Medical Centre	Recruiting
Sale, Australia
Contact: Novartis 41613241111
Royal Melbourne Hospital	Recruiting
VIC, Australia
Contact: novartis 41643241111
Westmead Hospital	Recruiting
NSW, Australia
Contact: novartis 41613241111
Princess Alexandra Hospital	Recruiting
QLD, Australia
Contact: Novartis 41613241111
Queen Elizabeth Hospital	Recruiting
Sale, Australia
Contact: novartis 41613241111
Sir Charles Gairdner Hospital	Recruiting
WA, Australia
Contact: novartis 41613241111

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceticals ( External Affairs )
Study ID Numbers:	CRAD001A2421
Study First Received:	September 1, 2006
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00371826 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:

Renal transplantation
everolimus
Immunosuppressants

Study placed in the following topic categories:

Everolimus
Anti-Infective Agents
Cyclosporine
Immunologic Factors
Antifungal Agents

Mycophenolate mofetil
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Everolimus
Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors

Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 09, 2009