NCT00171392

Brief Summary

The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

February 2, 2011

Status Verified

February 1, 2011

Enrollment Period

1.3 years

First QC Date

September 12, 2005

Last Update Submit

February 1, 2011

Conditions

Prevention of Acute Rejection After Kidney Transplantation

Keywords

Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium, tacrolimus.

Outcome Measures

Primary Outcomes (1)

  • Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

Secondary Outcomes (5)

  • Incidence of biopsy proven acute rejection

  • Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)

  • Quality of life related to GI symptoms (GIQLI scale)

  • Full blood count

  • Gastrointestinal Adverse Events (check-list)

Interventions

Enteric-coated mycophenolate sodiumDRUG

Eligibility Criteria

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

You may qualify if:

  • First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
  • Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

You may not qualify if:

  • Subjects expected to discontinue tacrolimus therapy;
  • Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline;
  • Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

February 2, 2011

Record last verified: 2011-02