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A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01292226
First received: February 3, 2011
Last updated: February 8, 2011
Last verified: February 2011
History of Changes
  Purpose

This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.


Condition Intervention Phase
Kidney Transplantation
 Drug: mycophenolate mofetil [CellCept]
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relationships Between Pharmacokinetic and Pharmacodynamic Strategies for Assessment of the Risks for Acute Rejection and Side Effects of Mycophenolate Mofetil

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correlation of pharmacokinetic (total and free mycophenolic acid [MPA] concentrations) to pharmacodynamic (inosine monophosphate dehydrogenase [IMPDH] II activity levels and IMPDH I and II gene expression) parameters. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pharmacodynamic parameters (IMPDH II activity, IMPDH I + II gene expression) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Correlation between MPA concentrations and clinical outcome (graft rejection, adverse events, patient survival) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Correlation between pharmacodynamic parameters (IMPDH II activity, IMPDH I + II gene expression) and clinical outcome (graft rejection, adverse events, patients survival) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Correlation between IMPDH inhibition and acute graft rejection [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
1g orally b.i.d, 24 weeks
Other Name: CellCept

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age
  • Patients undergoing primary kidney transplantation

Exclusion Criteria:

  • Recipients of multiple organ transplants
  • Prior therapy with CellCept
  • Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
  • Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292226

Locations
Italy
Bari, Italy, 70124
Brescia, Italy, 25123
Coppito, Italy, 67100
Napoli, Italy, 80131
Roma, Italy, 00168
Torino, Italy, 10126
Verona, Italy, 37126
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01292226     History of Changes
Other Study ID Numbers: ML19835
Study First Received: February 3, 2011
Last Updated: February 8, 2011
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013