Clinical trial NCT01672957: An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal allograft transplant participants initiated on combined immunosuppressive treatment containing mycophenolate mofetil

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil in accordance with the indication provided by the SmPC of mycophenolate mofetil
* Date of study enrollment is the date of kidney transplantation

Exclusion Criteria:

* Contraindication included in the SmPC for capecitabine (Xeloda) prevailed, like: Hypersensitivity to active ingredient or any of the excipients of the product; Pregnancy and lactation

Primary outcomes:
measure: Creatinine Clearance at 1 Month After Transplantation
timeFrame: Month 1
measure: Creatinine Clearance at Month 6 After Transplantation
timeFrame: Month 6
measure: Creatinine Clearance at Month 12 After Transplantation
timeFrame: Month 12
measure: Glomerular Filtration Rate (GFR) at Month 1 After Transplantation
timeFrame: Month 1
measure: GFR at Month 6 After Transplantation
timeFrame: Month 6
measure: GFR at Month 12 After Transplantation
timeFrame: Month 12
Secondary outcomes:
measure: Mean Dose of Mycophenolate Mofetil
timeFrame: Baseline, Months 1, 6, and 12
measure: Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
timeFrame: Baseline, Months 1, 6, and 12
measure: Percentage of Participants With Acute Rejection
timeFrame: Baseline to Month 1, Months 2 to 6, Months 7 to 12
measure: Percentage of Participants With Graft Survival
timeFrame: Months 1, 6, and 12
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Pecs
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: