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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01672957
First received: August 22, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This observational study will evaluate renal function in patients who underwent renal allograft transplantation and are started on combined immunosuppressive tr eatment containing CellCept (mycophenolate mofetil). Eligible patients will be f ollowed for 12 months following transplantation.


Condition
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 ]

Estimated Enrollment: 140
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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 transplant patients initiated on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept)

Criteria

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 ClinicalTrials.gov identifier: NCT01672957

Contacts
Contact: Reference Study ID Number: ML27844 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Hungary
Recruiting
Budapest, Hungary, 1082
Recruiting
Pecs, Hungary, 7624
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: NCT01672957     History of Changes
Other Study ID Numbers: ML27844
Study First Received: August 22, 2012
Last Updated: July 7, 2014
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on July 08, 2014