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

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ClinicalTrials.gov Identifier: NCT01672957
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date August 22, 2012
First Posted Date August 27, 2012
Results First Submitted Date August 16, 2016
Results First Posted Date October 11, 2016
Last Update Posted Date October 11, 2016
Study Start Date September 2011
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 16, 2016)
  • Creatinine Clearance at 1 Month After Transplantation [ Time Frame: Month 1 ]
    Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
  • Creatinine Clearance at Month 6 After Transplantation [ Time Frame: Month 6 ]
    Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
  • Creatinine Clearance at Month 12 After Transplantation [ Time Frame: Month 12 ]
    Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
  • Glomerular Filtration Rate (GFR) at Month 1 After Transplantation [ Time Frame: Month 1 ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure.
  • GFR at Month 6 After Transplantation [ Time Frame: Month 6 ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.
  • GFR at Month 12 After Transplantation [ Time Frame: Month 12 ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.
Original Primary Outcome Measures
 (submitted: August 22, 2012)
Renal function: calculated glomerular filtration rate (GFR) during the 12 months following transplantation [ Time Frame: approximately 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: August 16, 2016)
  • Mean Dose of Mycophenolate Mofetil [ Time Frame: Baseline, Months 1, 6, and 12 ]
  • Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil [ Time Frame: Baseline, Months 1, 6, and 12 ]
    Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.
  • Percentage of Participants With Acute Rejection [ Time Frame: Baseline to Month 1, Months 2 to 6, Months 7 to 12 ]
    Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.
  • Percentage of Participants With Graft Survival [ Time Frame: Months 1, 6, and 12 ]
    Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation.
Original Secondary Outcome Measures
 (submitted: August 22, 2012)
  • Mean dosage of CellCept/combined immunosuppressive drugs during the 12 months following transplantation [ Time Frame: approximately 2 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]
  • Graft survival/occurrence of acute rejection [ Time Frame: approximately 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Renal allograft transplant participants initiated on combined immunosuppressive treatment containing mycophenolate mofetil
Condition Kidney Transplantation
Intervention
  • 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.
    Other Name: CellCept
  • 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.
Study Groups/Cohorts Renal Transplant Participants
Renal transplant participants who will be subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, will be followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurs first. The choice of treatment will be made prior to enrolment by the treating physician. The treatment will be administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC).
Interventions:
  • Drug: Mycophenolate Mofetil
  • Drug: Immunosuppressive Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 2, 2016)
128
Original Estimated Enrollment
 (submitted: August 22, 2012)
8080
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT01672957
Other Study ID Numbers ML27844
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2016