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

Kidney Transplantation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672957
• Other study ID #: ML27844
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: July 1, 2016
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function: calculated glomerular filtration rate (GFR) during the 12 months following transplantation		approximately 2 years	No
Secondary	Mean dosage of CellCept/combined immunosuppressive drugs during the 12 months following transplantation		approximately 2 years	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No
Secondary	Graft survival/occurrence of acute rejection		approximately 2 years	No