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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 12, 2012
Last updated: February 1, 2016
Last verified: February 2016
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.

Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational, Non-interventional Survey of Renal Allograft Recipients Receiving CellCept as Part of Their Immunosuppressive Protocol

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Average dose of CellCept used in immunosuppressive protocols in Serbia [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Average dose of concomitant immunosuppressive drugs [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average duration of post-transplant period for patients in Serbia receiving CellCept [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 414
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Renal allograft recipients receiving CellCept as part of their immunosuppressive protocol

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01707550

Belgrade, Serbia, 11000
NIS, Serbia, 18000
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01707550     History of Changes
Other Study ID Numbers: ML25048 
Study First Received: October 12, 2012
Last Updated: February 1, 2016
Health Authority: Sebia: Medicines and Medical Devices Agency processed this record on February 07, 2016