NCT01672957

An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil

Non-interventional Clinical Study With Target of Kidney Function Follow-up in Routine Clinical Practice on De Novo Kidney Transplant Recipients Who Are on CellCept Immunosuppressive Combination Therapy in Routine Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 128 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study will evaluate renal function in participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months following transplantation.

Detailed description

The participant sampling method used in the Orange study was consecutive sampling, a non-probability sampling method where each participant meeting the study's inclusion and exclusion criteria is selected and enrolled in the study until the pre-set sample size is achieved. Thus, in the Orange study de novo kidney transplanted participants, who were on mycophenolate mofetil immunosuppressive combination therapy in routine clinical practice, were selected in a consecutive manner (a non-probability sampling method) if they met the inclusion/exclusion criteria until 128 participants were recruited to the study.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician.
DRUG	Immunosuppressive Therapy	Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2012-08-27
• Last updated: 2016-10-11
• Results posted: 2016-10-11

Locations

2 sites across 1 country: Hungary