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ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 22, 2012
Last updated: July 1, 2016
Last verified: July 2016
This observational study will evaluate renal function in patients who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing CellCept (mycophenolate mofetil). Eligible patients will be followed for 12 months following transplantation.

Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Open-label, Non-interventional Study for the Follow-up of Renal Function in de Novo Kidney Transplant Patients Treated With Immunosuppressive Therapy Containing CellCept in Routine Clinical Practice (ORANGE Study)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Renal function: calculated glomerular filtration rate (GFR) during the 12 months following transplantation [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean dosage of CellCept/combined immunosuppressive drugs during the 12 months following transplantation [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Graft survival/occurrence of acute rejection [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: September 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Renal allograft transplant patients initiated on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing CellCept in accordance with the indication stated in the current Hungarian label and with local therapeutic guideline
  • Date of study enrollment is the date of kidney transplantation

Exclusion Criteria:

  • Contraindications for CellCept according to the current Hungarian label:
  • Hypersensitivity to active ingredient or any of the excipients of the product
  • Pregnancy and lactation
  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: NCT01672957

Budapest, Hungary, 1082
Pecs, Hungary, 7624
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01672957     History of Changes
Other Study ID Numbers: ML27844 
Study First Received: August 22, 2012
Last Updated: July 1, 2016
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Mycophenolate mofetil
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on September 29, 2016