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NCT00240955 Clinical Trial

Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients

Renal Transplantation Clinical Trial

Official title:
Efficacy and Safety of Two Immunosuppressive Regimens Mycophenolate Sodium (EC-MPS) With Short-term Steroid Use or Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00240955
Other study ID # CERL080A2404E1
Secondary ID
Status Completed
Phase Phase 4
First received October 14, 2005
Last updated February 21, 2017
Start date March 2004
Est. completion date May 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria/ Exclusion Criteria

- All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained

Other protocol-defined exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Enteric-coated Mycophenolate sodium (EC-MPS)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of enteric-coated mycophenolate sodium based on adverse event (AE) reporting.
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