NCT00238979

Brief Summary

The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

2.1 years

First QC Date

October 12, 2005

Last Update Submit

November 1, 2011

Conditions

Renal Transplantation

Keywords

Renal transplantation, Enteric-coated mycophenolate sodium

Outcome Measures

Primary Outcomes (1)

  • Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.

Secondary Outcomes (5)

  • Safety based on renal function within 6 months after medication switch.

  • Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3

  • Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3

  • Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.

  • Graft survival and patient survival 6 months post medication switch.

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
  • Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
  • In a stable condition in terms of graft function.

You may not qualify if:

  • Patients who had taken an investigational drug within four weeks prior to study entry
  • History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
  • Thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<2,500/mm3), and/or hemoglobin \<6.0 g/dL prior to enrollment
  • Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

January 1, 2003

Primary Completion

February 1, 2005

Last Updated

November 2, 2011

Record last verified: 2011-11