PK-PD Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients

NCT00281619 | Completed

• 2 other identifiers: CEL420 MPA (PK-PD)CEL420
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant

Keywords

Pediatric Kidney Transplant; Kidney Transplant; CellCept; Mycophenolate mofetil; Mycophenolic Acid; MPA

Outcome Measures

Primary Outcomes (5)

• 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):

  6 months

• Drug Measurement of MPA and MPA-G

  6 months

• IMPDH Assay

  6 months

• Mitogenesis Assays and

  6 months

• Determination of CD25 Expression.

  6 months

Secondary Outcomes (5)

• Concomitant medications and MPA (CellCept) drug diary (study visits 1-4)

  6 months

• Physical Exam (study visits 1-4)

  6 months

• Safety Laboratory tests (study visits 1-4)

  6 months

• Dietary Monitoring (study visits 2,3 & 4)

  6 months

• Adverse Event Reporting (study visits 1-4).

  6 months

Study Arms (1)

Mycophenolic Acid (CellCept)

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

Drug: CellCept (mycophenolate mofetil); Behavioral: Dietary Monitoring; Behavioral: Drug Diary; Procedure: Blood Sampling

Interventions

CellCept (mycophenolate mofetil) DRUG

Mycophenolic Acid (CellCept)

Dietary Monitoring BEHAVIORAL

Mycophenolic Acid (CellCept)

Drug Diary BEHAVIORAL

Mycophenolic Acid (CellCept)

Blood Sampling PROCEDURE

Mycophenolic Acid (CellCept)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Male subjects and non-pregnant female subjects aged 2-17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy, per clinical care.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexander A. Vinks, PharmD., PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 25, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

US (1)