Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients - Full Text View

Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients (RAD001)

This study is not yet open for participant recruitment.

Verified by Novartis, April 2009

First Received: March 6, 2008 Last Updated: April 2, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00634920

Purpose

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

Condition	Intervention	Phase
Chronic Allograft Nephropathy	Drug: everolimus Drug: cyclosporine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Controlled Randomized Open-Label Multicenter Study Evaluating 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

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:

Renal function measured by Iohexol or Cr EDTA (Crom Ethylenediaminotetra acetate) clearance at randomization after 12 and 36 months

Secondary Outcome Measures:

Progression of chronic allograft nephropathy assessed by protocol biopsies findings at 12 and 36 months Occurrence of treatment failures up to and at 12, 24 and 36 months Time to first diagnosed malignancy Development and magnitude of proteinuria

Estimated Enrollment:	250
Study Start Date:	March 2008

Arms	Assigned Interventions
1: Active Comparator everolimus	Drug: everolimus everolimus
2: Experimental cyclosporine	Drug: cyclosporine cyclosporine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634920

Contacts

Contact: Novartis

41613241111

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceticals ( External Affairs )
Study ID Numbers:	CRAD001ASE01
Study First Received:	March 6, 2008
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00634920 History of Changes
Health Authority:	Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines

Keywords provided by Novartis:

De novo renal transplantation

Study placed in the following topic categories:

Everolimus
Anti-Infective Agents
Cyclosporine
Immunologic Factors
Urologic Diseases
Antifungal Agents

Disease Progression
Kidney Diseases
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
Urologic Diseases
Therapeutic Uses
Antifungal Agents
Kidney Diseases
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 10, 2009