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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01672957
First received: August 22, 2012
Last updated: August 16, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Kidney Transplantation
Drug: Mycophenolate Mofetil
Drug: Immunosuppressive Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Creatinine Clearance at 1 Month After Transplantation [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Dose of Mycophenolate Mofetil [ Time Frame: Baseline, Months 1, 6, and 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil [ Time Frame: Baseline, Months 1, 6, and 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 128
Study Start Date: September 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Renal allograft transplant participants initiated on combined immunosuppressive treatment containing mycophenolate mofetil
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
  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

Locations
Hungary
Budapest, Hungary, 1082
Pecs, Hungary, 7624
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01672957     History of Changes
Other Study ID Numbers: ML27844 
Study First Received: August 22, 2012
Results First Received: August 16, 2016
Last Updated: August 16, 2016
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 09, 2016