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

Kidney Transplantation Clinical Trial

Official title:

Observational, Non-interventional Survey of Renal Allograft Recipients Receiving CellCept as Part of Their Immunosuppressive Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707550
• Other study ID #: ML25048
• Status: Completed
• Phase: N/A
• First received: October 12, 2012
• Last updated: November 1, 2016
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sebia: Medicines and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Recipients of renal allograft

• Patients receiving CellCept

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average dose of CellCept used in immunosuppressive protocols in Serbia		9 months	No
Primary	Average dose of concomitant immunosuppressive drugs		9 months	No
Secondary	Average duration of post-transplant period for patients in Serbia receiving CellCept		9 months	No