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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01707550
First received: October 12, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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
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

Resource links provided by NLM:

U.S. FDA Resources

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: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707550

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01707550     History of Changes
Other Study ID Numbers: ML25048
Study First Received: October 12, 2012
Last Updated: February 27, 2013
Health Authority: Sebia: Medicines and Medical Devices Agency

Additional relevant MeSH terms:
Mycophenolate mofetil
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013