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Drug Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients
This study is currently recruiting participants.
Verified by Children's Hospital Medical Center, Cincinnati, December 2006
Sponsors and Collaborators: Children's Hospital Medical Center, Cincinnati
Hoffmann-La Roche
Information provided by: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00281619
  Purpose

The purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose. The results may lead to better dosing based on individual needs.


Condition Intervention Phase
Kidney Transplant
Drug: CellCept (mycophenolate mofetil)
Behavioral: Dietary Monitoring
Behavioral: Drug Diary
Procedure: Blood Sampling
Phase IV

MedlinePlus related topics: Kidney Transplantation
Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title: Development of Population Pharmacokinetic-Pharmacodynamic (PK-PD) Models of Mycophenolic Acid for Bayesian Dose Individualization in Pediatric Kidney Transplant Patients

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • The following outcome measures will be performed at study visit 2 (2-3 days post-transplant), study visit 3 (6-9 days post-transplant), and study visit 4 (3-6 months post-transplant):
  • Drug Measurement of MPA and MPA-G
  • IMPDH Assay
  • Mitogenesis Assays and
  • Determination of CD25 Expression.

Secondary Outcome Measures:
  • Concomitant medications and MPA (CellCept) drug diary (study visits 1-4)
  • Physical Exam (study visits 1-4)
  • Safety Laboratory tests (study visits 1-4)
  • Dietary Monitoring (study visits 2,3 & 4)
  • Adverse Event Reporting (study visits 1-4).

Estimated Enrollment: 24
Study Start Date: January 2006
Detailed Description:

This is an open-label, inpatient-outpatient population pharmacokinetic-pharmacodynamic (PK-PD) study of mycophenolic acid (MPA) in pediatric subjects (age 2-17 years) who have had a recent kidney transplant, as well as during the stable renal transplant period when on a stable oral regimen of MPA. The primary objective of this study is to develop population pharmacokinetic-pharmacodynamic (PK-PD) models for mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) in order to improve individualized pediatric dosing. Subjects will have been receiving CellCept as part of their clinical standard of care. It is anticipated that the clinical portion of the study for each patient will be approximately six months post renal transplant with four study days: a screening visit pre-transplant, two 10-hour inpatient days at 2-3 and 6-9 days post-transplant, and one (up to 10 hour) outpatient visit at 3-6 months post-transplant. Pharmacokinetic and pharmacodynamic measurements will be conducted at various time points (up to 9 hours post dose) on study days 2, 3, and 4. Safety data to be collected will include physical examinations, measurement of vital signs, and laboratory assessments, as well as data on adverse events and clinical outcomes.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects and non-pregnant female subjects aged 2 to 17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy. Subjects may be enrolled up to their 18th year.
  • Minimum weight of 11 kg.
  • A signed and dated IRB approved parental / guardian informed consent form and an IRB-approved child assent form if applicable.
  • A high probability for compliance with and completion of the study.
  • For post-transplant study period: Subjects with stable kidney allografts who are at least 3 months post-transplant and who have received the same regimen of MMF (with cyclosporine or tacrolimus) for at least 30 days before the study visit (3-6 months post-transplant).
  • May have clinically important abnormalities on clinical and /or laboratory evaluations only as these abnormalities relate to an underlying condition as determined by the principal investigator.
  • Other variations from established normal ranges may be acceptable if they are not clinically significant in the opinion of the investigators.

Exclusion Criteria:

  • Any medical condition (active or chronic) or prior surgery that may interfere with the pharmacokinetic behavior of MMF (absorption, distribution and elimination) as determined by the PI.
  • Active systemic infection.
  • History of substance abuse.
  • Signs or symptoms of active hepatitis (a history of hepatitis B or C virus infection is permitted).
  • Known history of or suspected infection with human immunodeficiency virus (HIV).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281619

Contacts
Contact: Denise H. Maseck, RN 513-636-0157 Denise.Maseck@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Denise H. Maseck, RN     513-636-0157     Denise.Maseck@cchmc.org    
Principal Investigator: Alexander A. Vinks, PharmD.,PhD.            
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Hoffmann-La Roche
Investigators
Principal Investigator: Alexander A. Vinks, PharmD., PhD Children's Hospital Medical Center, Cincinnati
  More Information

Study ID Numbers: CEL420 MPA (PK-PD), CEL420
Study First Received: January 23, 2006
Last Updated: December 14, 2006
ClinicalTrials.gov Identifier: NCT00281619  
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Pediatric Kidney Transplant
Kidney Transplant
CellCept
Mycophenolate mofetil
Mycophenolic Acid
MPA

Study placed in the following topic categories:
Mycophenolate mofetil
Mycophenolic Acid

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009