An Observational Study of CellCept (Mycophenolate Mofetil) in Renal Allograft Recipients

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT01707550
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational survey study will capture all renal transplant patients in Serbia who are currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-16
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Recipients of renal allograft
• Patients receiving CellCept

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average dose of CellCept used in immunosuppressive protocols in Serbia	9 months
Average dose of concomitant immunosuppressive drugs	9 months

Secondary Outcome Measures

Name	Time	Method
Average duration of post-transplant period for patients in Serbia receiving CellCept	9 months