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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01707550
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease
Kidney Transplantation

Study Type : Observational
Actual Enrollment : 414 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational, Non-interventional Survey of Renal Allograft Recipients Receiving CellCept as Part of Their Immunosuppressive Protocol
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Primary Outcome Measures :
  1. Average dose of CellCept used in immunosuppressive protocols in Serbia [ Time Frame: 9 months ]
  2. Average dose of concomitant immunosuppressive drugs [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Average duration of post-transplant period for patients in Serbia receiving CellCept [ Time Frame: 9 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01707550

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01707550     History of Changes
Other Study ID Numbers: ML25048
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action