Status:
COMPLETED
Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Function
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 chro...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00634920
Start Date
March 1 2008
End Date
May 1 2013
Last Update
August 13 2014
Active Locations (8)
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1
Novartis Investigative Site
Aarhus N, Denmark, 8200
2
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
3
Novartis Investigative Site
Herlev, Denmark, 2730
4
Novartis Investigative Site
Odense C, Denmark, DK-5000